Dornase Alfa: Patients will receive an intravenous dose of Dornase alfa twice within within 24±6 hours after symptom onset, administered as a bolus.
Isotonic Saline Solution: Patients will receive an intravenous dose of Isotonic saline solution twice within within 24±6 hours after symptom onset, administered as a bolus.
Study summary
The goal of this (multicentric, randomised, placebo-controlled single-blinded; phase 2) clinical trial is to test the hypothesis that DNase 1 administration leads to a reduction in systemic immune response measured in patients after acute ischaemic stroke compared to control treatment.
Participants will receive intravenous DNase 1 (500 µg/kg) or placebo (NaCl 0.9%) twice within 24±6 hours after symptom onset (last seen well). Blood samples will be taken at baseline, day 1 and 3. Personal visits will occur on baseline, day 1, 3 and discharge date. A telephone interview will be conducted on day 30±3.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 Criteria:
* Presence of any of the following conditions: Sinus or cerebral venous thrombosis, intracerebral haemorrhage, subarachnoid haemorrhage on qualified imaging (cCT with CT-A or MRI with MR-A). However, petechial haemorrhagic transformations of the index infarct and cerebral microhaemorrhages may be included.
* Active malignant tumour disease in the last 6 months.
* Current known immunosuppression due to immunomodulatory medication with immunosuppressive dose or underlying immunosuppressive disease (e.g. HIV).
* Acute fulminant infectious disease in the last 7 days (fever \> 38.5°C or suspected by the Investigator).
* Breastfeeding or pregnant woman, women of childbearing age without known use of contraceptives 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 surgery without 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 protein products derived from Chinese hamster ovary cells.
* Thrombocytopenia, leukocyte count \<1500/μl.
* Known participation in another clinical trial investigating a drug and/or medical product in the last 7 days before study inclusion.
* Severe renal insufficiency with GFR≤29 ml/min/ 1.73m³ and/or renal insufficiency requiring dialysis.
Primary outcome measure(s)
Concentration of interleukin-1 beta in blood of patients with acute ischemic stroke receiving Dornase alfa compared to placebo treatment with Isotonic Saline Solution. — 24±6 hours after symptom onset Outcome of reduced systemic immune response measured by interleukin-1 beta concentration \[pg/ml\] (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).
Trial sites (5)
Facility
City
Region
Status
Institute for Stroke and Dementia Research, Ludwig Maximilian University Munich, University Hospital
Munich
Bavaria
Not Yet Recruiting
Charité Universitätsmedizin
Berlin
Germany
Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
Germany
Recruiting
MHH Hannover
Hanover
Germany
Recruiting
TUM Klinikum München
Munich
Germany
Not Yet Recruiting
More Ludwig-Maximilians - University of Munich trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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