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

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ClinicalTrials.gov Identifier: NCT05880524
Recruitment Status : Not yet recruiting
First Posted : May 30, 2023
Last Update Posted : March 19, 2024
Sponsor:
Collaborators:
University Hospital Erlangen
University Hospital Regensburg
Information provided by (Responsible Party):
Martin Dichgans, Ludwig-Maximilians - University of Munich

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Inflammatory Response Drug: Dornase Alfa Drug: Isotonic Saline Solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Monocentric, randomised, placebo-controlled single-blinded, Phase 2 trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)
Estimated Study Start Date : December 2024
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pulmozyme
Dornase alfa; intravenous administration; 500 µg/kg
 Drug: Dornase Alfa
Patients will receive an intravenous dose of Dornase alfa twice within within 24±6 hours after symptom onset, administered as a bolus.
Other Name: Pulmozyme
Placebo Comparator: Isotonic Saline Solution
NaCl 0,9 %; intravenous administration; 0,5 ml/kg
 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.
Other Name: NaCl 0,9%


Outcome Measures
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Primary Outcome Measures :
  1. Concentration of interleukin-1 beta in blood of patients with acute ischemic stroke receiving Dornase alfa compared to placebo treatment with Isotonic Saline Solution. [ Time Frame: 24±6 hours after symptom onset ]
    Outcome of reduced systemic immune response measured by interleukin-1 beta concentration [pg/ml] (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).


Secondary Outcome Measures :
  1. cfDNA concentration in blood. [ Time Frame: 24±6 hours after symptom onset ]
    Measurement of cell-free DNA (cfDNA) concentration [ng/ml] in blood at day 1 (24±6 hours after symptom onset) compared to the placebo group with experimental analysis.

  2. DNase 1 activity in blood. [ Time Frame: 24±6h after symptom onset ]
    Comparison of DNase 1 activity [µU/ml] in blood of both treatment arms measured by Enzyme-linked Immunosorbent Assay (ELISA).

  3. Concentration of DNase 1 in blood. [ Time Frame: 24±6h after symptom onset ]
    Analysis of the DNase 1 concentration [ng/ml] in patient blood treated with Dornase alfa compared to the placebo group by Enzyme-linked Immunosorbent Assay (ELISA).

  4. Analysis of the composition of the leukocyte population in blood. [ Time Frame: 24±6 hours after symptom onset ]
    Analysing the leukocyte population [%] in blood using flow cytometry in both treatment arms.

  5. Interleukin-6 concentration in blood after treatment. [ Time Frame: 24±6 hours after symptom onset ]
    Measurement of the interleukin-6 concentration [pg/ml] in blood samples (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).

  6. Caspase 1 concentration in blood after treatment. [ Time Frame: 24±6 hours after symptom onset ]
    Analysing the caspase 1 concentration [pg/ml] in blood (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).

  7. Assessment of patient safety after Dornase alfa treatment. [ Time Frame: 30±3 days after symptom onset ]

    Safety aspects of intravenous investigational drug administration in acute ischemic stroke patients will be assessed by monitoring all study patients for 30±3 days and analysis of their:

    • routine clinical diagnostics (worsening stroke is defined as a) progression, hemorrhagic transformation of the index stroke documented by radiological imaging; b) life-threatening need for intervention; c) death from the index stroke; and/or d) increasing disability (as measured by an increase of ≥ 4 points from the lowest NIHSS score measured during hospitalization, or a 1-point increase in mRS),
    • laboratory parameters (hemoglobin, platelets, neutrophil granulocytes, leukocytes, CRP, GFR, creatinine, IL-6) and
    • number of adverse events assessed by CTCAE current version.

  8. Comparison of the incidence of infections and antibiotic treatment in both treatment arms. [ Time Frame: 30±3 days after symptom onset ]
    Comparing the incidence of infections and antibiotic treatment after Dornase alfa and Isotonic Saline Solution treatment over a period of 30±3 days after symptom onset.

  9. Functional neurological outcome scores (National Institute of Health Stroke Scale [NIHSS, 0-42] and Modified Rankin Scale [mRS, 0-6]) at both treatment arms. [ Time Frame: 30±3 days after symptom onset ]
    Analysing changes of neurological scores (National Institute of Health Stroke Scale [NIHSS, 0-42] and Modified Rankin Scale [mRS, 0-6]) from baseline to last visit 30±3 days after symptom onset.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05880524


Contacts
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Contact: Arthur Liesz, Prof. Dr. +49 89 4400 46242 arthur.liesz@med.uni-muenchen.de
Contact: Saskia Wernsdorf +49 89 4400 46119 saskia.wernsdorf@med.uni-muenchen.de

Locations
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Germany
Institute for Stroke and Dementia Research, Ludwig Maximilian University Munich, University Hospital
Munich, Bavaria, Germany, 81377
Contact: Arthur Liesz, Prof. Dr.    +49 89 4400 46242    arthur.liesz@med.uni-muenchen.de   
Contact: Saskia Wernsdorf    +49 89 4400 46119    saskia.wernsdorf@med.uni-muenchen.de   
Principal Investigator: Martin Dichgans, Prof. Dr.         
Sub-Investigator: Arthur Liesz, Prof. Dr.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
University Hospital Erlangen
University Hospital Regensburg
Investigators
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Study Director: Martin Dichgans, Prof. Dr. Institute for Stroke and Dementia Research, LMU Hospital
More Information
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Responsible Party: Martin Dichgans, Sponsor-Delegated Person and Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT05880524    
Other Study ID Numbers: RESCIND-1-2023
2022-003410-37 ( EudraCT Number )
First Posted: May 30, 2023    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Inflammation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis