Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)

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

The goal of this (monocentric, 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 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
    Germany

    Site Not Available

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