Lake Buena Vista, Florida

Fascial Manipulation in Cerebral Palsy Rehabilitation

Introduction Fascial manipulation (FM) is a manual therapy method developed by physiotherapist Luigi Stecco. It involves the treatment of deep fascia related to muscles or superficial fascia of subcutaneous tissue, which is made up of connective tissue. The goal of FM is to normalize the function of muscle-related fascia, allowing movement to return to normal and overstrained or painful structures to heal. Superficial fascial treatment is needed, for example, in the treatment of surgical scars and swelling The method has been used to treat various musculoskeletal disorders, with evidence supporting its effectiveness. FM can be used in the rehabilitation of children with CP (cerebral palsy) to treat stiffness caused by the non-neural component of spasticity. Both neural and non-neural factors influence the abnormal movement patterns caused by spasticity in children with CP. Recent research suggests that non-neural factors are functionally more significant. Spasticity caused by upper motor neuron damage leads to an increase in the extracellular matrix (ECM) of the muscle. The main component of the extracellular matrix is hyaluronan (HA), which facilitates internal muscle and intermuscular sliding and myofascial force transmission. The mechanical properties of the muscle, such as stiffness and viscosity, often change with spasticity, as the increased concentration of HA associated with spasticity can increase the viscosity of the ECM and the collagen content in the muscle. This affects both active and passive movement and alters the force production and coordination between agonist and antagonist muscles. Increased resistance to active movement causes fatigue and pain. Increased ECM viscosity increases the stretch on the perimysium and the muscle spindle attached to it, sensitizing spindle activation. These non-neural peripheral factors are believed to cause muscle stiffness. There have been few studies on the effectiveness of FM in the rehabilitation of children with CP. The limited studies and practical observations suggest that treatment targeting muscle-related fascia may be a beneficial addition to the rehabilitation of children with CP. High-quality studies on the effectiveness of FM in general musculoskeletal rehabilitation are scarce. A recent systematic review indicates that the level of evidence for FM is low to moderate. A systematic review on children with CP has recently been published. In Finland, the rehabilitation of children with CP has largely relied on the NDT/Bobath framework, although its effectiveness has been strongly criticized in a recent meta-analysis. The need for further research is evident. Therapists trained in NDT/Bobath use their experience, reflection, and knowledge gained from various continuing education courses in their work. The NDT-Bobath approach serves as the framework for clinical decision-making in therapy. It emphasizes the importance of the child's own activity in the development of agency. Research Objectives The aim is that the therapy method used in the study will provide additional benefits to the rehabilitation of children with CP by enabling better movement patterns, more effective training, and more economical movement, thereby enhancing the child's/youth's functional capacity. The indication for fascia manipulation is to prevent and correct the typical functional limitations caused by CP and to enable better functional capacity. Based on clinical observations, the acute effect of FM on the movement of children with CP is promising. The aim of this study is to investigate the acute and longer-term effects of FM using objective methods. The researchers will conduct an eight-week randomized and controlled rehabilitation intervention study with children with CP, comparing the effect of FM on walking ability and lower limb joint movements to therapy conducted according to current best rehabilitation practices. Through an interview study (with parents after the intervention), the researchers will investigate the potential added value of FM in the participant's involvement and empowerment, i.e., the ability to participate more diversely in various social activities and cope with hobbies, school, and other community activities. The assumption is that movement will be less strenuous. An interview with the child's own physiotherapist after the fascia manipulation intervention aims to identify any changes in functional capacity and therapy situations observed by the physiotherapist. The Gross Motor Function Classification Scale (GMFCS) is used to determine the severity of the motor impairment in children with CP, describing gross motor function, i.e., movement. The classification uses levels 1-5 (Terveyskylä, Lastentalo, CP-vamma lapsella). The target group for this study are children at GMFCS level 2 (independent walking without assistive devices, often requiring orthoses, with some difficulty moving outside the home, e.g., stairs) and GMFCS level 3 (independent walking with assistive devices, such as a walker or rollator, with significant difficulty moving outside the home, often using a wheelchair outdoors). Hypotheses: I) Acute Effect: Compared to conventional neurological physiotherapy, fascia manipulation more effectively reduces spasticity and stiffness in the ankle and other lower limb joints and decreases co-contraction of the extensor-flexor muscles of the ankle during walking. Participants will include those in GMFCS levels 2 and 3. They rarely have differentiated movement in the ankle, so any changes will be visible in the movements of the knee and hip. II) Longitudinal Effect: Compared to conventional neurological physiotherapy, fascia manipulation treatment better promotes the function of lower limb joints, which is reflected in an improved walking pattern (Gait Deviation Index) and positive changes in walking performance (6-minute walk test, primary outcome measure) and efficiency (oxygen consumption). III) Improved mobility increases and eases patients' participation in various activities outside the home, such as attending school and engaging in hobbies, and transitions in these situations Study Design and Patient Recruitment The researchers will conduct an 8-week randomized and controlled rehabilitation intervention study, recruiting 20 children aged 7-14 years with a diagnosis of spastic CP (GMFCS levels 2-3) . The participants will be recruited from the HUS/ULS patient registry. Sample Size and Randomization Power calculations were performed based on the primary outcome measure (6-minute walk test). Based on clinical observations, the researchers estimate that FM increases walking speed by approximately 10% (0.05 m/s), which corresponds to an improvement of about 60 meters in the 6-minute walk test. With an effect size of 0.8, the required sample size would be 15 (power = 90% and α = 0.05), but the researchers are accounting for a 25% dropout rate and will recruit a total of 20 children with CP. Participants will be randomized into two groups of 10: 1) fascia manipulation group (intervention group I) and 2) conventional physiotherapy group (intervention group II). Randomization will be done in blocks of four based on age, gender, GMFCS level, and baseline walking ability (6-minute test) and walking pattern (Gait Deviation Index). Once a group of four participants is formed based on registry data, they will be contacted, and both the child and the guardian will be asked about their willingness to participate in the study. If the child and guardian are willing to participate, the participants will be assigned to groups using a computer-based randomization tool, distributing 2-4 participants (considering GMFCS level, age, gender, and 6-minute walk test result) to intervention group I and intervention group II. If the child or guardian declines, a new participant will be sought using registry data (considering age, gender, and severity of CP), and their willingness to participate in the study will be asked. This process will continue until the intervention groups are formed. The study is prepared to increase the sample size by an additional 10 (5+5) patients if necessary. The decision will be made after 20 (10+10) patients have been studied and the interventions have been carried out. If there is attrition or other issues that complicate statistical analysis, the sample size will be increased. Intervention Group I In Intervention Group I, children will undergo motion analysis measurements at the beginning of the study, receive one fascia manipulation treatment, and then have the measurements repeated after the treatment to assess the acute response to the therapy. The group will receive 8 FM intervention treatments (once a week) either at the child's home or at the physiotherapist's office. The therapy intervention will last about two months. After the treatments, the children will undergo motion analysis measurements again to assess the longitudinal effect of the therapy. It is noteworthy that during the fascia manipulation treatment, the regular weekly physiotherapy based on stretching will continue. Intervention Group II In Intervention Group II, children will undergo initial measurements, after which the physiotherapist will guide them through stretching exercises, and final measurements will be taken to assess the acute response to the stretching. During the two-month intervention, the children will receive the same therapy as before (traditional physiotherapy) and, in addition, a remotely conducted stretching program guided by the physiotherapist. Thus, the children will receive physiotherapy twice a week. This arrangement is to more reliably assess the potential added value of fascia manipulation. After the two-month intervention, the children in Intervention Group II will undergo the same motion analysis measurements as at the beginning, and then Intervention Group II will receive FM therapy eight times. The duration of the intervention is about two months. A semi-structured interview will be conducted with the relative (parent) of the participant after the fascia manipulation intervention. A total of about 10 parents will be interviewed. The aim of the qualitative study is to document the impact of FM on the participant's daily life, schooling, social participation, and the effects on the lives of the participant's parents. The study will also interview the participant's physiotherapist (a total of about 10). The researcher will contact the interviewee to arrange a suitable time. The interview can be conducted either via Teams remote connection or face-to-face. The interview will last about 30 minutes. The interviews will be recorded if the interviewees give their consent. The recorded interviews will be transcribed anonymously, and personal data will not be linked to the anonymized data.

Photodynamic Treatment in the Management of Residual Biofilm - a Crossover Study

The antimicrobial effect of aPDT is based on the principle that light as such activates a non-toxic, photosensitive molecule, generating reactive oxygen species that kill the bacterium. Applications of aPDT in dentistry include the treatment of bacterial and fungal infections and the diagnosis of lesions. In dental treatment, regular photodynamic treatment with dual-light has been shown to be beneficial for the gingival health of dental implants and to reduce the amount of visible plaque (VPI). Photodynamic treatment has also been shown to slow down the amount of biofilm re-forming in the mouth. The simultaneous use of blue light and near-infrared light operating at 810 nm and 405 nm has been shown to reduce Staphylococcus aureus more effectively than using only a single light source. The use of indocyanine green as a photosensitizer in dual-light phototherapy has also been shown to be effective in eliminating Streptococcus oralis. Indocyanine green has otherwise low toxicity to dental restorative materials and to non-target host tissue. Indocyanine green is also very suitable as a photosensitizer due to its high absorption peak. Indocyanine green-mediated photodynamic therapy as an adjunct to non-surgical periodontal treatment has been shown to improve treatment outcomes for dental adhesive tissue diseases with statistically significant results at 3 months and 6 months after treatment with periodontitis patients. There is in vitro evidence for the efficacy of indocyanine green specifically against periodontal pathogens. Tooth decay, gingivitis and periodontitis are common oral infections associated with tooth extraction and are caused by bacteria living in the mouth. In total, more than 500 different species of bacteria can be found in the mouth. The normal flora of a healthy mouth is rich in a variety of microbes that start to multiply from birth. Bacteria of different species form biofilms, or plaques (bacterial communities), on the tooth surfaces, some of which mutate to become pro-inflammatory. Most oral diseases are multifactorial. A high-sugar diet, poor oral hygiene, general diseases, dry mouth, ill-fitting dentures or antimicrobial therapy can affect the microbial balance in the mouth and thus contribute to the development of oral diseases. Locally, oral areas are affected by possible plaque overgrowth, orthodontic appliances, open caries deposits and partially erupted wisdom teeth, which provide an easy attachment site for bacterial pathogens and a challenging area to clean. As biofilm accumulates at the gum line over several days, it causes the tissue to release inflammatory neurotransmitters that call on defense cells from the bloodstream to destroy bacteria. Inflammation of the gums appears as swelling, redness and bleeding on cleaning. If gingivitis becomes chronic, it is a risk for periodontitis, which is the inflammation and tissue destruction of the attachment tissues. Periodontitis is manifested in the mouth as inflammation of the attachment tissues, with deepening of the gum pockets around the tooth, increased tooth mobility, and alveolar leakage on X-rays. Careful, daily self-care and regular dental hygiene are the most important preventive measures for oral and jaw infections and dental infections. The surface of the tooth does not clean itself like the surface of the mucous membrane or skin through natural taming, so it must be cleaned mechanically. It is recommended to brush the teeth twice a day for two minutes with fluoride toothpaste and to brush the interdental spaces every 24 hours with a suitable instrument. Lumoral® is a powerful LED light device with a mouthpiece operating blue light at 405 nm and near-infrared light at 810 nm. The Lumoral® treatment involves a combination of the use of mouth rinse inculding indocyanine green , Lumorinse®, and the Lumoral® dual-light mouthpiece. A tablet of Lumorinse® is dissolved in 30 millilitres of water to form a mouthwash, which is swished around the oral cavity for 60 seconds. After using the mouthwash, the Lu-moral® mouthpiece is placed in the mouth for 10 minutes of light activation. After use, the teeth are cleaned by brushing and cleaning the interdental spaces. The active photosensitive substance of Lumorinse® adheres to the surface of the dental plaque, and the targeted light from the mouthpiece produces an antibacterial effect in the mouth. Lumoral® does not cause bacterial resistance, making it suitable for regular use. The treatment is bacterio-selective, meaning that it targets only harmful microbes in the mouth and does not affect the normal oral flora. The purpose of this study is to investigate the amount of residual biofilm by comparing conventional tooth cleaning with the additional cleaning of teeth with Lumoral®. The aim is to determine whether Lumoral® treatment reduces the amount of residual biofilm in the mouth in adults in general good oral health.

Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care

Disturbed sleep and insomnia are common among shift workers, and disturbed sleep is considered a key factor in other health risks associated with shift work. However, there are no established treatment practices for treating insomnia in shift workers. This study aims to evaluate the effectiveness of Cognitive-Behavioural Therapy for Insomnia (CBT-I) tailored for social and health care sector shift workers whose work includes night shifts. Furthermore, the study will assess the shift workers' experiences of the acceptability and feasibility of CBT-I from their perspective. The study will also examine which features of shift work and employee characteristics promote or interfere with the effectiveness of the tailored CBT-I. The study is a randomised controlled trial. Participants will be shift workers in the social and health care sector who work in three or two shifts, including night shifts, and have significant insomnia symptoms. Participants will be recruited through occupational health services (OHS) and social media posts. The FIOH study group will carry out the measurements of the participants. Participants will complete the baseline measures (sleep diary, actigraphy and questionnaires) and then will be randomly assigned to receive the research intervention (CBT-I tailored to the shift work context; six individual sessions) or the control intervention (sleep hygiene counselling; one individual session). The interventions will be delivered by the nurses of the participants´ OHS and the FIOH. Participants will complete the follow-up measures after the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment. The results of the study can be utilised in OHS to guide and treat shift workers with insomnia as part of supporting their work ability.

A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML

Interventions for the Wellbeing of Students At the University of Helsinki

Groups for health (G4H) is a manualized brief intervention based on social identity theory aiming to improve mental well-being by promoting social connectedness and belonging as well as reducing loneliness by building the participants' social identity capital in the context of group experience. The Effectiveness of the G4H intervention has been studied in two Australian randomized controlled trials (RCT) as well as in one Australian controlled experiment. The RCT studies showed that G4H decreased loneliness and social anxiety and increased group memberships significantly more than treatment as usual and that in comparison with cognitive-behavioral therapy (CBT), both interventions reduced loneliness as effectively in the beginning of the intervention period, but the G4H group showed continued reduction in loneliness at the end of the intervention period and in the follow-up. Both interventions reduced depressive symptoms significantly and there were no differences between G4H and CBT. In all three controlled studies on the effects of G4H, inclusion criteria for the study were low mood and loneliness. At present research on the effectiveness of G4H outside Australia is lacking and the cost-effectiveness of the G4H intervention or determinants of intervention effectiveness have not been evaluated. Consequently, this study focuses on the feasibility, effectiveness, and cost-effectiveness of the G4H among the University of Helsinki (UH) students in Finland. Moreover, students will not be excluded based on lack of loneliness or symptoms of depression. The participants are students at the UH who have either; A) applied for three brief interventions for students' well-being: "Ryhmät kuntoon" -course (G4H at the UH), groups facilitated by the study psychologists, or online course for students' well-being (active intervention groups), or B) students who are not attending to any active interventions for mental well-being or promotion of studying skills (no-intervention control group). The students will be recruited for the active intervention groups and no-intervention group by email, website, and social media advertisements circulated by the UH media and communications services, communications services at the faculties, student health services, and student organizations. The interventions will be organized at the UH and are free for the UH students. Data on the outcome measures is collected before and during the intervention as well as in 1- and 3-months follow-ups. Appropriate statistical methods including linear mixed model analyses will be used to study the effectiveness of the G4H intervention. In addition to the outcome measures, data on the participants' and facilitators' background will be collected. The participant background questionnaire is filled out before the intervention and it consists of information on age, gender, birth date, mother tongue, marital status, household composition, residential situation, employment status, education, income, subjective health, readiness to attend to the intervention, social support, academic skills, and situational intrinsic and extrinsic motivation. Data gathered from UH registries include information on study rights (faculty, degree programs, fields of study) and their starting years, on active and passive registration, completed degrees, and information on learning and studies, such as approaches to learning, experiences of the teaching-learning environment, stress, and experiences of study-related burnout during studies and work during studies (HowULearn and HowUStudy questionnaires). This data is gathered to account for these factors in the statistical analyses and to analyze if these factors influence the effectiveness and cost-effectiveness of the intervention. To investigate how facilitators' individual professional and personal characteristics may predict intervention process and effectiveness, G4H facilitators will fill self-report measures both before and during the interventions. Before initiating the intervention, facilitators will fill questionnaires related to personality traits (Extra-Short Five questionnaire), attachment style (Experiences in Close Relationships -questionnaire), and self-experiences in close personal relationships (Trainee Background Information Form). After the week 3 session, the facilitators' experiences of their current skillfulness, difficulties, and emotions in group work is measured based on an abbreviated version of the self-reported Trainee Current Practice Report. In addition, the facilitators' experiences of the group working alliance will be surveyed, based on a modified version of the Therapist Working Alliance Inventory Short Form. In the collection of the quantitative data, both paper-and-pencil and electronic versions of the questionnaires will be used. Those in the active intervention groups will fill in the data as part of the sessions during the interventions or in the frequency of the sessions if the questionnaires are provided electronically and those in the no-intervention group will fill-in the questionnaires based on the email reminders of the electronic data collection system (time interval between reminders resembling interval between sessions in the active intervention groups). Data is collected before the intervention, during the intervention (week 3), immediately after the intervention and in one- and three-months follow-ups. In addition to the quantitative data collection the investigators will explore the challenges and possibilities identified in the G4H-intervention regarding inclusion and equality. Three methods of data collection are used: 1) participant observations, 2) interviews with G4H participants and facilitators and 3) focus groups with young people who belong to minorities. In this sub-study, the aim is to examine challenges and possibilities identified in the G4H-intervention regarding inclusion and equality and whether G4H promotes long-term inclusion and equality among the participants. Participant observations are conducted in the meetings of the G4H group and interviews are conducted with a subset of facilitators and intervention participants in the end of the intervention period. The follow-up interviews will be conducted 6 months, 12 months and 3 years after the first interview. The facilitators and participants of G4H will be mailed information about the study and an informed consent will be acquired before the first session. The participant observation focuses on the interaction in the groups and the experiences of facilitators and participants, in order to gain knowledge about how the groups work, what kinds of issues they deal with and especially how inclusion and equality are accomplished in the groups (are there minority participants, can participants influence the themes dealt with in the groups, or is inclusion and equality taken into account in some other ways in the groups). Following the ethnographic research tradition, the researcher takes part in the activities of the groups instead of observing them from the outside. Depending on their preferences, the study participants (both facilitators and participants in the groups) will be interviewed in a group, in pairs or individually, in facilities located outside the university (for example in a study room of a local library). In addition, focus groups are arranged with young people belonging to minority groups with increased risk of marginalization or mental health problems. In the focus groups, young people are asked to comment on the design/description of G4H in terms of equality and inclusion, with the goal of enhancing inclusivity by listening to their views on the interventions and accumulation knowledge on the fit between the interventions and their specific needs. The focus groups target young people belonging to sexual and/or gender minorities, young people with immigrant background and young people with disabilities. These groups represent youth minorities with a high risk of loneliness. To date, research on their experiences of different services is lacking. All the interviews will be tape-recorded and later transcribed. Written informed consent is gathered from all participants. The participants who have given their consent have the option to withdraw from the study at any point. Students who are currently undergoing other (mental health) treatment will not be interviewed to avoid causing them further stress.

A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older

Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial

STEPCARE Trial (Clinical trials identifier:NCT05564754) includes adult out-of-hospital cardiac arrest (OHCA) patients, with sustained ROSC, who remain comatose after resuscitation. STEPCARE is a factorial Trial, where all participants are randomized regarding three different interventions (minimal or deep sedation, target mean arterial pressure 65mmHg or 85mmHg, temperature management with or without a device). Patients with suspected or confirmed intracerebral hemorrhage, trauma or hemorrhage as reasons of arrest, those previously randomized to STEPCARE and patients with allergy to adhesive material or skin injury in the frontal-temporal area will be excluded (the latter two specific to this substudy). The investigators aim to assess whether a new, algorithm-based index derived from continuous EEG (cEEG) recording is superior to retrospective visual analysis of cEEG in predicting functional outcome after OHCA, assessed restrospectively from early phase recordings, using the best hour within the 9-12-hour time interval after ROSC. The cEEG will be collected using a commercially available Brainstatus device in selected centers participating in the STEPCARE Trial. cEEG will be visible to clinical team in centers using cEEG in routine monitoring, but blinded for those who do not routinely monitor cEEG in OHCA patients. C-Trend Index is blinded to clinicians and researchers, and will be analyzed retrospectively, after the primary outcome has been collected of the last patient of this substudy. The primary outcome of this substudy is the functional outcome 6 months after OHCA, defined as modified Rankin Scale score (dichotomized as favourable mRS 0-3, and unfavourable mRS 4-6), assessed by blinded outcome assessors. The investigators will compare accuracy (with separate comparisons of sensitivity and specificity) of C-Trend Index 9-12 hours after ROSC with the visual assessment of cEEG. C-Trend Index above a predefined cut-off value 20 is defined as indicative of favorable outcome, while in the visual assessment continuous or nearly continuous normal-voltage background without abundant discharges is considered indicative of favorable outcome . To demonstrate a 10% difference in the accuracy, a sample size of 271 patients is needed. To account for loss of patients due to early wake-up, loss of follow-up, and technical issues in recordings the investigators aim at recruiting 300 patients. As secondary research questions the study will also assess: - The predictive accuracy off C-Trend Index in predicting unfavorable functional outcome, compared with visual analysis of cEEG - The predictive accuracy of C-Trend Index using cut-off values 50 and 80 at 9-12 hours from ROSC in predicting favorable and unfavorable functional outcome - Whether the predictive ability or the optimal cut-off value of C-Trend Index in predicting favorable and unfavorable functional outcome is affected by the three different interventions of the STEPCARE study

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland

Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis

Introduction Total blood loss including intraoperative, drain output, and hidden blood loss equals to 40% of blood volume in patients undergoing posterior spinal fusion for paediatric spinal deformities. Despite the perioperative use of tranexamic acid and gelatine matrix with human thrombin, 14% of patients with adolescent idiopathic scoliosis (AIS) and 73% of patients with neuromuscular scoliosis (NMS) require allogenic red blood cell infusion (Soini et al. NASSJ 2022). Early use of pooled human plasma (PHP) may reduce total blood loss in these patients, but there are no studies in the paediatric population undergoing major surgery on this subject. Objective To compare pooled human plasma (PHP, OCTAPLAS) vs. crystalloid (PLASMALYTE, comparator) for intraoperative bleeding, drain output, and hidden blood loss as well as the sum of these components (total blood loss) in children undergoing posterior spinal fusion for AIS. Adverse events will be recorded and reported as minor (skin reaction) or major (severe allergic reaction, transfusion related acute lung injury, TRALI; deep surgical site infection, neurologic injury). The investigators hypothesize that the use of PHP in the early perioperative management will reduce intraoperative blood loss (primary outcome), drain output, and hidden blood loss accounting for total blood loss and reduce the need for perioperative allogenic red blood cell infusion (secondary outcome) without increasing the risk for adverse events. Additionally, postoperative pain (opioid consumption and pain score, secondary outcome) may be decreased. Outcomes Primary outcome is intraoperative blood loss (blood loss in mL after wound closure). Secondary outcomes include need for allogenic red blood cell infusion (percentage of patients at hospital release, health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption, pain visual analogue score), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection). Disease specific Scoliosis Research Society (SRS)-24 questionnaires are filled out preoperatively, at 6 months and 24 months during postoperative outpatient clinic visits. Study design A randomized, double-blinded, multicenter (Helsinki and Turku University Hospitals, Finland) clinical trial according to CONSORT criteria. After randomization, patients will be given in a blinded fashion (except for anaesthesia nurse) either 10 ml/kg (maximal dose 400 ml) pooled human plasma (OCTAPLAS or 10ml/kg (maximal dose 400 ml) crystalloid (PLASMALYTE) as an intravenous 1-hour infusion, as part of the standard anaesthesia of scoliosis surgery, starting at one hour before incision. Scoliosis surgery is a complex procedure, in addition to standard pharmacological treatment and anaesthesiologic control of blood pressure, surgical technique significantly affects blood loss during surgery. To dependently determine the effectiveness of OCTAPLAS to reduce blood loss, the operating room needs to be blinded for intervention. Selection of study population Trial subjects consist of individuals who are planned to undergo PSF for scoliosis as standard practice. Individuals are 10 to 21 years of age. The study population consists of adolescents with idiopathic scoliosis (over 45 degrees) and neuromuscular scoliosis (over 50 degrees). All individuals are required to give informed consent either by patient, legal representative/parent, or both, when appropriate. Patients under legal age of independent consent (less than 15 or 18) need parents' or caretakers' consent in addition to their own consent. Some neuromuscular scoliosis patients are not capable of giving their own informed consent. In that case the consent is given only by the child´s legal representative or parent. Suitability for this trial is determined by the need of surgical intervention for scoliosis, thus the patient population who would benefit from the treatment under investigation includes individuals who are minors or are not capable of giving informed consent, thus inclusion of this patient population in this investigation is justified. The clinical trial is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical trials on persons able to give informed consent, or by other research methods, and the incapacitated subjects have received the information referred to in Article 29(2) in a way that is adequate in view of their capacity to understand. The sponsor considers that the conditions for the inclusion of incapacitated subjects in the trial, as laid out in Art 31 of the CTR, are considered fulfilled. Inclusion criteria Subjects meeting all the criteria below may be included in the study. To be eligible for inclusion, each subject must meet each of the following criteria at Screening and must continue to fulfil these criteria at Baseline (Visit 1). Patients will be included in the study if they fulfil the following criteria: - Written informed consent. - Aged between 10 and 21 years of age - Scoliosis requiring posterior scoliosis surgery using all pedicle screw technique for AIS (>45-degree major curve) or NMS (>50-degree major curve); - Normal whole spine MRI except for the spinal deformity (only for patients with adolescent idiopathic scoliosis as patients with neuromuscular scoliosis do not typically undergo MR images as they would need general anaesthesia). Exclusion criteria Subjects are excluded from the study if any of the following criteria is met at Screening or at Baseline: - Immunoglobulin A-deficiency - Need for anteroposterior surgery - Need for three column vertebral resection - Smoking - Diabetes mellitus - Abnormalities in blood coagulation (thromboplastin time below above or below of normal values, 70-130%) - Blood trombosytes less than 150 x E9/l - Body mass index over 40 - Allergy or hypersensitivity to study medications or their ingredients - Pregnancy or breast-feeding, aim of becoming pregnant during the study. - Participation in another study and receipt of any other investigational agent during 2 year period of current investigation - Inability to provide written informed consent - Any significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study. - A history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements. - Known history of, or documented positive hepatitis B or C or HIV infection - Prior or concurrent malignancy 12 - Aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 3 x upper-limit of normal - Creatinine clearance (CrCl) < 60 ml/min measured by 24-hour urine collection or estimated from the Cockcroft and Gault formula - Clinically significant ECG findings as judged by the investigator - Amiodarone medication - Hyperkalemia - Renal insufficiency - AV-block - Metabolic or respiratory alkalosis - Hypochlorhydria - Hypersensitivity for active component or additives - Contraception requirements: Combined hormonal contraception should be stopped 4 weeks prior to receiving IMP. Progestin-only contraceptives including pills, implant and intrauterine system, and Copper IUD) and sexual abstinence are allowed forms of contraception. Withdrawal Patient can withdraw from trial at any point at will. The infusion is administered during anesthesia and primary outcome can be evaluated in all patients. Randomization and blinding The randomization is carried out by research coordinator, using a computer-generated method (www.sealedenvelope.com), in 1:1 allocation ratio. Randomization aims at equal distribution of the active treatment throughout the study period and between the different centres. To balance the groups, stratification will be conducted according to centre (Helsinki vs. Turku), developmental disability (Yes vs. No), and weight (less than 60 kg vs. 60 kg or more). The study will be conducted in a double-blind fashion. Study treatment assignment will be blinded for both the investigators and the subject. At each local investigation site, a defined group of trained, unblinded personnel will be responsible for preparing the intravenous study drug and for delivering the drug to blinded personnel involved in the subsequent patient treatment and care. The person preparing the drug will not participate in other aspects of the study. The blind can be broken in case a significant medical adverse event occurs (such as suspected allergic reaction). Any intentional or unintentional breaking of the blind will be recorded and reported to the sponsor as soon as possible. Blinding and coding lists saved are managed in secure database and under the responsibility of the Chief Investigator, who has access to this database. In case of unblinding is needed, the unblinding process is conducted as follows: Criteria for Unblinding: Unblinding will be performed only if it is deemed essential for the immediate clinical management of a participant. Unblinding may be initiated if a serious adverse event (SAE) occurs that, in the investigator's judgment, requires knowledge of the treatment assignment to make critical decisions for patient care. Procedure for Unblinding: The investigator should first attempt to contact the trial's chief investigator or research coordinator to discuss the need for unblinding. If the chief investigator or research coordinator agrees that unblinding is necessary, the randomization code will be accessed. If the chief investigator or research coordinator cannot be reached in a reasonable time frame, the investigator may proceed to unblind, documenting the reason and the time. Accessing the Randomization Code: The randomization code is securely stored in a sealed envelope at the trial site in patient folder and in an electronic randomization system accessible only by authorized personnel. The investigator or treating physician must log the details of the unblinding event, including the date, time, and rationale for unblinding, in the participant's medical record, from where it transferred eCRF. Surgery Surgery - Posterior surgery for scoliosis will be conducted according to current standard. Surgical planning of implant placement and the need for Ponte procedures will be carried out preoperatively. Each patient will be placed in the prone position and the posterior elements will be exposed using electrocautery. Ponte osteotomy will be conducted as described previously (Ponte et al, 1985). After full facetectomies, ligamentum flavum and laminae are resected for 5 mm posteriorly at three adjacent levels. The deformity will be corrected using bilateral segmental pedicle screw instrumentation and by en bloc vertebral column derotation. Spinal fusion is carried out using autograft acquired from facetectomies and osteotomies with bone graft extenders (iFactor, Cerapedics, Ic., Westminster, CO). Spinal cord monitoring (MEP, SSEP, lumbar nerve root EMG with or without pedicle screw stimulation) will be undertaken in all patients. A single subfascial drain (Hemovac Ch14; Zimmer, Warsaw, Indiana) will be placed and kept for 24 hours post-operatively. A sterile wound dressing will be applied at the end of surgery. All patients will be mobilized using a standardized protocol: sitting on the day of surgery, minimum four steps on 1st postoperative day (AIS), and progressively increasing walking distance with an aim to discharge patients on 4th -5th postoperative day. Discharge criteria include ability to walk independently (AIS) or sit independently (NMS), no need for opioid prescription, and ability to empty bladder spontaneously without a significant urinary retention (>200 mL). Anaesthesia All patients will have total intravenous anaesthesia including dexmedetomidine, propofol and remifentanil-infusions. Mean arterial pressure will be kept between 65 mmHg and 75 mmHg during surgery and for the first 24 hours postoperatively. Cefuroxime and Vancomycin will be used as antibiotic prophylaxis. All patients will receive pain control by oral long-acting Targiniq™ twice daily along with on demand short-acting oral oxycodone. The analgesic management also includes regular oral paracetamol. All patients will receive an intravenous bolus of tranexamic acid (30 mg/kg, maximum dose 1500 mg) within 30 minutes before incision and then an infusion (10 mg/kg/h, maximum dose 500 mg/h) during surgery. Intraoperative blood loss will be measured and recorded as the amount of blood collected in the cell saver, surgical wound dressings will be weighed during surgery, excluding any irrigation with saline. Allogenic red blood cells will be transfused according to a threshold level of Hb 80 g/L during surgery or during the hospital stay. Pooled frozen human plasma will be given according to randomization or if the blood loss exceeds 50% of the patient's total blood volume (safety criteria). Platelets will be infused if the blood loss is more than 100% of the blood volume. The estimated blood volume will be calculated using a formula of 70 ml/kg x weight (kg). Arterial gas analyses will be performed minimum twice intraoperatively and at the postoperative recovery unit to rule out hyponatremia and hyperkalemia. Vasopresssin is not part of our standardized anaesthesia protocol. Assessment Day 1 of the trial is day of the surgery, and the trial medication and placebo will be given to patients. During surgery Intraoperative blood loss is determined by weighting of surgical folds and measurement of surgical suction collection. Mean arterial pressure (MAP), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), heart rate, blood oxygen saturation, BIS/SQI, body temperature and noradrenalin infusion (μg/kg/min) is recorded at anaesthesia induction, after patient positioning in prone position on operating table, after surgical incision, after implantation of screws and rods, after correction of scoliosis and after wound closure. Patient haemoglobin concentration and haematocrit is recorded at end of surgery, 4 hours, and 8 hours after surgery. Pain visual analogue scale (VAS 0-10) is recorded at 4 and 8 hours after end of surgery. Day 2 to 5 are the 1st to 3rd postoperative days. Patients are hospitalised at surgical ward. At day 2 to 5 patient haemoglobin concentration and hematocrit is recorded. At day 2 wound drain is removed and total drain output is recorded. PCA pump is removed at day 3 and total oxycodone consumption is recorded. Peroral oxycodone consumption is recorded at day 4 to 5. Pain VAS is recorded at day 2 to 4. Nausea, skin rash and other possible other adverse reactions are recorded. Scoliosis radiographs, SRS-24 questionnaire, Pain VAS, adverse events, and pain medication are recorded at 6 and 24 months. End of Trial Trial ends 24 months after surgery of the last participant. The Sponsor and/or the trial steering committee have the right at any time to terminate the study for clinical or administrative reasons. The end-of-trial is the date of the last visit of the last subject. The end of study visit includes assessment of primary and secondary outcome measures, assessments of safety and compliance with study treatments, and recording of concomitant medications. Unblinded interim analysis will be conducted after enrollment of 50% of the predetermined number of patients. If the experimental group shows >20% higher intraoperative blood loss, >20% higher incidence of blood transfusions or >20% higher complication rate, as compared to comparator the trial will be terminated. The analysis and possible recommendation of study termination will be made by independent external DSMB. Description of treatment OCTAPLAS is a solvent/detergent (S/D) treated, pooled human plasma indicated for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or who are undergoing cardiac surgery or liver transplantation; and plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP). OCTAPLAS is infused based on ABO-blood group compatibility. OCTAPLAS is marketed in the Member States of the Union. The marketing authorisations include major surgery. 10 ml/kg OCTAPLAS (maximal dose 400 ml) is infused in 60-minute infusion prior to surgical infusion. This should increase the patient's plasma coagulation factor levels by approximately 15-25%, resulting in lower intraoperative blood loss. PLASMALYTE Injection is a sterile, nonpyrogenic intravenous solution which does not contain bacteriostatic or antimicrobial agents or added buffers. 19 PLASMALYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One litre has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. PLASMALYTE is marketed in the Member States of the European Union. The marketing authorisations include major surgery. 10 ml/kg (maximal dose 400 ml) PLASMALYTE is infused in 60-minute infusion prior to surgical infusion. PLASMALYTE A serves as placebo. PLASMALYTE is the standard crystalloid used in the participating investigation sites. The study medication will be supplied to pharmacy by Helsinki and Turku University hospitals and retrieved at the end of the study. The investigator is responsible for the control of the treatments under investigation. Adequate records for the receipt and disposition of the IMP will be maintained. The investigator will use a standard prescription manner of the institution and the research nurse will collect the medication from the pharmacy. Accountability and subject compliance with study treatments will be assessed by maintaining dispensing and return records. Safety reporting Adverse events will be reported according to Common Terminology Criteria for adverse effects (CTCAE, V.5, 2017) and graded as an assessment of the causal relationship to the investigational medicinal product. The PI or a delegated physician is responsible for registering and reporting AE/AR or serious AEs or serious ARs (SAE/SAR). All assessments will be documented in HUSeCRF and registered at the in-hospital treatment daily and follow-up visit at 3 months and 24 months post-surgery. Thereafter, the safety registration and reporting will be finalised. A SAE/SAR will be reported to the chief investigator within 24 hours after the PI becomes aware of event. If the PI at one of the participating sites suspects a suspected unexpected serious adverse reaction, they will inform the chief investigator with 24 hours. SUSARs will be reported to Fimea with CIOMS form, which transfers them to EudraVigilance database. If the event is fatal or life threatening, the event will be reported immediately. Any event that is neither fatal nor life threatening is reported within 7 days of the investigators' knowledge of such an event. In the case of a event, all participating investigators will be informed of the event, and any consequences related to the execution of the trial will be communicated. Data Safety Monitoring Board The investigators and institutions involved in this clinical trial are under clinical trial-related safety monitoring. Independent Data Safety Monitoring Board (DSMB) evaluates risks and if necessary the efficacy of investigational product. DSMB recommends the sponsor either to continue or terminate the ongoing investigation. The DSMB is composed of paediatric orthopaedic surgeon, paediatrician, paediatric anaesthesiologist and biostatistician, all members of DSMB are experienced in clinical research involving underage patients. All trial documents are available to the public at the European Medicines Agency website Clinical Trials Information System (CTIS) database. If protocol deviations occur, these are reported from PIs to the chief investigator as soon as possible and noted in the eCRF separately. Statistics The sample size has been evaluated with significance level (alpha) 5%, power (1-beta) 70% with expected mean blood loss in Plasmalyte group (NMS 1085 ml (SD 1049), AIS 554 ml (SD 349) and Octaplas (NMS 700ml, AIS 409). Expected blood loss is derived from institutional treatment registry (Soini et al NASSJ 2022). Allowing 5% lost to follow-up 97 patients for both groups are required. The statistical analyses are adjusted using linear mixed model with developmental disability diagnosis and weight as independent variables. Intention to treat analysis set is used for primary and secondary outcomes and safety analysis set for AEs. Data handling Data are collected locally and reported continuously after every visit to an electronic Case Report Form (HUSeCRF). The PIs at each investigative site are responsible for data entry into the HUSeCRF and for the validity of the data collected.