Testing Dornase Alfa to Calm Inflammation After Stroke
Tests Dornase Alfa against saline in adults after an ischemic stroke.
Plain-language title generated from the registry record
Registry title: Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)
Key facts
- Where
- Berlin, Hamburg, Hanover, and Munich, GermanySee the 5 sites
- Phase
- Phase 2
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, GermanyTaking people
- Klinikum der Universitaet Muenchen AöRMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ludwig-Maximilians - University of Munich
- Trial code
- NCT05880524EU 2024-516701-22-00
- Record updated
- 11 September 2026
- Original description
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.Read full original descriptionShow less
Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)
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.
Inclusion: 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: 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; Known participation in another clinical trial investigating a drug and/or medical product in the last 7 days before study inclusion; 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); Known allergies or intolerance to dornase alfa (Pulmozyme) or recombinant protein products derived from Chinese hamster ovary cells; Breastfeeding or pregnant woman, women of childbearing age without known use of contraceptives with positive urine or serum beta-human choriogonadotropin test; Thrombocytopenia, leukocyte count <1500/μl; Severe renal insufficiency with GFR≤29 ml/min/ 1.73m³ and/or renal insufficiency requiring dialysis; Estimated or known weight > 100 kg.