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

NCT ID: NCT05880524

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2026-01-31

Brief 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.

Conditions

Ischemic Stroke; Inflammatory Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pulmozyme

Dornase alfa; intravenous administration; 500 µg/kg

Group Type: ACTIVE_COMPARATOR

Dornase Alfa

Intervention Type: DRUG

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

NaCl 0,9 %; intravenous administration; 0,5 ml/kg

Group Type: PLACEBO_COMPARATOR

Isotonic Saline Solution

Intervention Type: DRUG

Patients will receive an intravenous dose of Isotonic saline solution twice within within 24±6 hours after symptom onset, administered as a bolus.

Interventions

Dornase Alfa

Patients will receive an intravenous dose of Dornase alfa twice within within 24±6 hours after symptom onset, administered as a bolus.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Pulmozyme; NaCl 0,9%

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Erlangen

OTHER

Sponsor Role: collaborator

University Hospital Regensburg

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Martin Dichgans

Sponsor-Delegated Person and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Dichgans, Prof. Dr.

Role: STUDY_DIRECTOR

Institute for Stroke and Dementia Research, LMU Hospital

Locations

Institute for Stroke and Dementia Research, Ludwig Maximilian University Munich, University Hospital

Munich, Bavaria, Germany

Countries

Germany

Central Contacts

Arthur Liesz, Prof. Dr.

Role: CONTACT

arthur.liesz@med.uni-muenchen.de

+49 89 4400 46242

Saskia Wernsdorf

Role: CONTACT

saskia.wernsdorf@med.uni-muenchen.de

+49 89 4400 46119

Facility Contacts

Arthur Liesz, Prof. Dr.

Role: primary

arthur.liesz@med.uni-muenchen.de

+49 89 4400 46242

Saskia Wernsdorf

Role: backup

saskia.wernsdorf@med.uni-muenchen.de

+49 89 4400 46119

References

Di G, Vazquez-Reyes S, Diaz B, Pena-Martinez C, Garcia-Culebras A, Cuartero MI, Moraga A, Pradillo JM, Esposito E, Lo EH, Moro MA, Lizasoain I. Daytime DNase-I Administration Protects Mice From Ischemic Stroke Without Inducing Bleeding or tPA-Induced Hemorrhagic Transformation, Even With Aspirin Pretreatment. Stroke. 2025 Feb;56(2):527-532. doi: 10.1161/STROKEAHA.124.049961. Epub 2025 Jan 27.

Reference Type: DERIVED

PMID: 39869712 (View on PubMed)

Other Identifiers

2022-003410-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RESCIND-1-2023

Identifier Type: -

Identifier Source: org_study_id