Authorised Therapeutic exploratory (Phase II) Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration

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

EU CTIS ID: 2024-516701-22-00

What this study is testing

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.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - 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

You likely can't join if

  • - 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.