Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration (ReSCInD)

Phase 2

Not yet recruiting

• Conditions: Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration
• Interventions: Drug: Isotonic Saline Solution; Drug: Dornase Alfa

• Registration Number: 2024-516701-22-00
• Lead Sponsor: Klinikum der Universitaet Muenchen AöR

Brief Summary

To test the hypothesis that DNase 1 administration leads to a reduction of systemic immune response as measured by blood interleukin-1 beta concentration at 24±6 hours after symptom onset (primary end point) in patients after acute ischemic stroke compared with control treatment.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-31
• Last Update Posted: 2025-06-04

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

• Patients with urgent suspected acute ischemic stroke with symptom onset (last-seen-well) to 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: Sinus or cerebral venous thrombosis, intracerebral hemorrhage, subarachnoid hemorrhage on qualifying imaging (cCT with CT-A or MRI with MR-A). However, petechial hemorrhagic transformation of index infarct and cerebral microhemorrhage may be included. - Active malignant tumor disease in the past 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 investigator) - Breastfeeding or pregnant woman, women of childbearing age (under 55 years) without known contraceptive use with positive urine or serum beta-human choriogonadotropin tests - Ischemic stroke or myocardial infarction in the previous 30 days - Surgery in the previous 30 days, except minor dermatologic, urologic, oral surgery, or gynecologic surgery without anesthesia and wound healing problems, 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 device in the 7 days prior to study enrollment - Severe renal insufficiency with GFR≤29 ml/min/ 1.73m3 and/or renal insufficiency requiring dialysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isotonic Saline Solution	Isotonic Saline Solution	NaCl 0,9 %; intravenous administration; 0,5 ml/kg
Pulmozyme	Dornase Alfa	Dornase alfa; intravenous administration; 500 µg/kg

Primary Outcome Measures

Name	Time	Method
The primary endpoint, IL-1 β concentration in the blood within 24±6 hrs after symptom onset, will be analyzed in the full analysis set, which comes as close as possible to the IIT principle. A mixed linear regression model is calculated with the IL-1 β value (at 24±6hrs & 3 d) as the dependent variable, the randomized group, the IL-1 β value at baseline & the time point, the interaction of time + group, as independent variables and the patient as a random effect.		The primary endpoint, IL-1 β concentration in the blood within 24±6 hrs after symptom onset, will be analyzed in the full analysis set, which comes as close as possible to the IIT principle. A mixed linear regression model is calculated with the IL-1 β value (at 24±6hrs & 3 d) as the dependent variable, the randomized group, the IL-1 β value at baseline & the time point, the interaction of time + group, as independent variables and the patient as a random effect.

Secondary Outcome Measures

Name	Time	Method
All secondary endpoints are analyzed descriptively, and differences between the two study arms are explored according to their level of measurement.		All secondary endpoints are analyzed descriptively, and differences between the two study arms are explored according to their level of measurement.

Trial Locations

Locations (5)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Charite Universitaetsmedizin Berlin KöR; 🇩🇪 Berlin, Germany

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum); 🇩🇪 Munich, Germany

Klinikum der Universitaet Muenchen AöR; 🇩🇪 Munich, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hanover, Germany

University Medical Center Hamburg-Eppendorf

🇩🇪Hamburg, Germany

Götz Thomalla

Site contact

+4940741050137

thomalla@uke.de