Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLudwig-Maximilians - University of Munich
About this trial
The goal of this (multicentric, 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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Dornase Alfa
DrugPatients will receive an intravenous dose of Dornase alfa twice within within 24±6 hours after symptom onset, administered as a bolus.
Isotonic Saline Solution
DrugPatients will receive an intravenous dose of Isotonic saline solution twice within within 24±6 hours after symptom onset, administered as a bolus.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: PulmozymeActive comparator 1 intervention
Group B: Isotonic Saline SolutionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
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.
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).
Time frame
24±6 hours after symptom onsetSecondary outcomes
1
cfDNA concentration in blood.
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.
Time frame
24±6 hours after symptom onset2
DNase 1 activity in blood.
Comparison of DNase 1 activity \[µU/ml\] in blood of both treatment arms measured by Enzyme-linked Immunosorbent Assay (ELISA).
Time frame
24±6h after symptom onset3
Concentration of DNase 1 in blood.
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).
Time frame
24±6h after symptom onset4
Analysis of the composition of the leukocyte population in blood.
Analysing the leukocyte population \[%\] in blood using flow cytometry in both treatment arms.
Time frame
24±6 hours after symptom onsetSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ludwig-Maximilians - University of Munich
Lead sponsor
University Hospital Erlangen
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
Source ClinicalTrials.gov