Last updated: March 18, 2024
Sponsor: Ludwig-Maximilians - University of Munich
Overall Status: Active - Not Recruiting
Phase
2
Condition
Stroke
Blood Clots
Cerebral Ischemia
Treatment
Dornase Alfa
Isotonic Saline Solution
Clinical Study ID
NCT05880524
RESCIND-1-2023
2022-003410-37
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with suspected acute ischemic stroke with symptom onset (last-seen-well)until Investigational drug application of less than 12 hours.
- Consent to participate in the study.
- Age ≥ 18 years.
- NIHSS ≥10 at admission.
Exclusion
Exclusion Criteria:
- Presence of any of the following conditions: Sinus or cerebral venous thrombosis,intracerebral haemorrhage, subarachnoid haemorrhage on qualified imaging (cCT withCT-A or MRI with MR-A). However, petechial haemorrhagic transformations of the indexinfarct and cerebral microhaemorrhages may be included.
- Active malignant tumour disease in the last 6 months.
- Current known immunosuppression due to immunomodulatory medication withimmunosuppressive dose or underlying immunosuppressive disease (e.g. HIV).
- Acute fulminant infectious disease in the last 7 days (fever > 38.5°C or suspected bythe Investigator).
- Breastfeeding or pregnant woman, women of childbearing age without known use ofcontraceptives with positive urine or serum beta-human choriogonadotropin test.
- Ischemic stroke or myocardial infarction in the previous 30 days.
- Surgery in the previous 30 days, except minor dermatological or gynaecological surgerywithout anaesthesia and wound healing disorders and patients with thrombectomy.
- Estimated or known weight > 100 kg.
- Known allergies or intolerance to dornase alfa (Pulmozyme) or recombinant proteinproducts derived from Chinese hamster ovary cells.
- Thrombocytopenia, leukocyte count <1500/μl.
- Known participation in another clinical trial investigating a drug and/or medicalproduct in the last 7 days before study inclusion.
- Severe renal insufficiency with GFR≤29 ml/min/ 1.73m³ and/or renal insufficiencyrequiring dialysis.
Study Design
Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Dornase Alfa
Phase: 2
Study Start date:
December 01, 2024
Estimated Completion Date:
January 31, 2026
Connect with a study center
Institute for Stroke and Dementia Research, Ludwig Maximilian University Munich, University Hospital
Munich, Bavaria 81377
GermanySite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.