International, Multicenter, Randomized, Single Blind, Placebo-controlled Study of Efficacy and Safety of CITOFLAVIN® in the Acute Period of Head Injury in Adults (MITRA)

  • STATUS
    Recruiting
  • days left to enroll
    84
  • participants needed
    320
  • sponsor
    POLYSAN Scientific & Technological Pharmaceutical Company
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Updated on 25 October 2022
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Summary

The study will access the efficacy and safety of treatment with CITOFLAVIN® in patients with non-penetrating moderately severe traumatic brain injury (TBI). The study recruits patients 18-60 years with TBI, corresponding to the clinical diagnosis of brain contusion, with GCS score 9 -14 at the time of inclusion , with the estimated time of initiation of therapy within 24 hours from the estimated or established time of trauma, with post-traumatic amnesia, confusion or disorientation and absence of indications for neurosurgery or other surgical intervention under general anesthesia.

Cytoflavin® (Inosine + Nicotinamide + Riboflavin + Succinic Acid) is a combination drug, which improves cerebral blood flow, activates metabolic processes in the central nervous system, restores impaired consciousness, promotes regression of neurological symptoms and improvement of cognitive functions of the brain.

Details
Condition Head Trauma,Closed
Treatment Placebo, Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid)
Clinical Study IdentifierNCT04631484
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company
Last Modified on25 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age from 18-60 (inclusive)
Clinical diagnosis of TBI, cerebral contusion of moderate severity without compression
The written consent of the legal representative or the decision of the council to include the patient in the study
Possibility of a full assessment of eye opening, speech and motor response by GCS
GCS at the time of inclusion 9 - 14 (inclusive)
Time of initiation of study drug therapy within 24 hours after the estimated or determined time of injury
The presence of post-traumatic amnesia, confusion and disorientation
Absence of indications for neurosurgery or other surgical intervention under general anesthesia
Normal brain CT scan, or the presence of subarachnoid hemorrhage and / or contusion foci of I-III types according to Kornienko and / or limited or diffuse cerebral edema
The expected duration of hospital stay >= 10 days
Absence of a disabling neurological or mental illness, information about the patient's disability prior to injury
Possibility to perform all procedures stipulated by the study protocol

Exclusion Criteria

The need to use the therapy prohibited by the study protocol
Concomitant injury, except for cases of damage to the skeleton, soft tissues, internal organs, which do not require (1) surgical intervention under general anesthesia, and (2) are not an independent indication for hospital treatment
Past / planned surgical intervention for the current episode of trauma under general anesthesia
Penetrating open TBI
Presence of the following lesions on the results of computed tomography (CT) of the brain performed prior to the patient's randomization
epidural hematoma or subdural hematoma
evidence of a previous head injury based on CT results
type IV contusion foci according to Kornienko's classification
Presence of any of the following risk factors for secondary brain injury at any time
Drug addiction
after TBI: hypoxia (SpO2 <90% based on pulse oximetry results); hypotension
(systolic blood pressure <90 mm Hg) or shock;hypothermia (body temperature <35
Depression of consciousness, presumably resulting from other reasons (for example, alcohol, drugs, drugs, poisonous substances)
° C); clinical signs of respiratory failure, the need for mechanical
The presence of aphasia due to focal brain damage, which prevents communication with the researcher
ventilation
Status epilepticus at the time of admission to the hospital or condition after an epileptic seizure
Pregnant and lactating women
Alcohol in saliva >=2 ‰ or a previous diagnosis of alcohol dependence
Availability of information about concomitant chronic disease in the stage of decompensation
Severe renal or heart failure requiring restriction of the volume of injected fluid
The presence of a condition or disease that, in the opinion of the investigator, jeopardizes the patient's safety if the patient participates in the study, or may interfere with the performance of examination procedures, an objective assessment of the patient's condition, or distort the assessment of the outcome of TBI
Participation in any clinical study less than 3 months before the start of the study
Intolerance to the components of CYTOFLAVIN®, anamnestic data on drug allergy to succinic acid, riboflavin, inosine, or nicotinamide
Patients who are employees of the research center and their families
Language barrier
Availability of information that the patient is a stateless person or a citizen of another state
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