[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506910":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":53,"interventions":66,"overallOfficials":78,"centralContacts":83,"locations":88,"responsibleParty":159,"collaborators":162,"id":167,"slug":168,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":169,"sex":174,"minAge":175,"maxAge":43,"enrollmentInfo":176,"targetDuration":43,"studyType":179,"phases":180,"briefSummary":182,"conditions":183,"keywords":43,"overallStatus":111,"whyStopped":43,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"Ludwig-Maximilians - University of Munich","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002Fml\\] (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).","24±6 hours after symptom onset",[14,17,21,24,27,30,33,37,40],{"measure":15,"description":16,"timeFrame":12},"cfDNA concentration in blood.","Measurement of cell-free DNA (cfDNA) concentration \\[ng\u002Fml\\] in blood at day 1 (24±6 hours after symptom onset) compared to the placebo group with experimental analysis.",{"measure":18,"description":19,"timeFrame":20},"DNase 1 activity in blood.","Comparison of DNase 1 activity \\[µU\u002Fml\\] in blood of both treatment arms measured by Enzyme-linked Immunosorbent Assay (ELISA).","24±6h after symptom onset",{"measure":22,"description":23,"timeFrame":20},"Concentration of DNase 1 in blood.","Analysis of the DNase 1 concentration \\[ng\u002Fml\\] in patient blood treated with Dornase alfa compared to the placebo group by Enzyme-linked Immunosorbent Assay (ELISA).",{"measure":25,"description":26,"timeFrame":12},"Analysis of the composition of the leukocyte population in blood.","Analysing the leukocyte population \\[%\\] in blood using flow cytometry in both treatment arms.",{"measure":28,"description":29,"timeFrame":12},"Interleukin-6 concentration in blood after treatment.","Measurement of the interleukin-6 concentration \\[pg\u002Fml\\] in blood samples (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).",{"measure":31,"description":32,"timeFrame":12},"Caspase 1 concentration in blood after treatment.","Analysing the caspase 1 concentration \\[pg\u002Fml\\] in blood (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).",{"measure":34,"description":35,"timeFrame":36},"Assessment of patient safety after Dornase alfa treatment.","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:\n\n* 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\u002For 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),\n* laboratory parameters (hemoglobin, platelets, neutrophil granulocytes, leukocytes, CRP, GFR, creatinine, IL-6) and\n* number of adverse events assessed by CTCAE current version.","30±3 days after symptom onset",{"measure":38,"description":39,"timeFrame":36},"Comparison of the incidence of infections and antibiotic treatment in both treatment arms.","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.",{"measure":41,"description":42,"timeFrame":36},"Functional neurological outcome scores (National Institute of Health Stroke Scale [NIHSS, 0-42] and Modified Rankin Scale [mRS, 0-6]) at both treatment arms.","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.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"RANDOMIZED","PARALLEL","Multicentric, randomised, placebo-controlled single-blinded, Phase 2 trial","TREATMENT",{"masking":50,"maskingDescription":43,"whoMasked":51},"SINGLE",[52],"PARTICIPANT",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"Pulmozyme","ACTIVE_COMPARATOR","Dornase alfa; intravenous administration; 500 µg\u002Fkg",[59],"Drug: Dornase Alfa",{"label":61,"type":62,"description":63,"interventionNames":64},"Isotonic Saline Solution","PLACEBO_COMPARATOR","NaCl 0,9 %; intravenous administration; 0,5 ml\u002Fkg",[65],"Drug: Isotonic Saline Solution",[67,73],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"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.",[55],[55],{"type":68,"name":61,"description":74,"armGroupLabels":75,"otherNames":76},"Patients will receive an intravenous dose of Isotonic saline solution twice within within 24±6 hours after symptom onset, administered as a bolus.",[61],[77],"NaCl 0,9%",[79],{"name":80,"affiliation":81,"role":82},"Arthur Liesz, Prof. Dr.","Institute for Stroke and Dementia Research, LMU Hospital","PRINCIPAL_INVESTIGATOR",[84],{"name":80,"role":85,"phone":86,"phoneExt":43,"email":87},"CONTACT","+49 89 4400 46169","arthur.liesz@med.uni-muenchen.de",[89,109,123,136,149],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Institute for Stroke and Dementia Research, Ludwig Maximilian University Munich, University Hospital","NOT_YET_RECRUITING","Munich","Bavaria","81377","Germany","DE",{"type":98,"coordinates":99},"Point",[100,101],11.57549,48.13743,{"lat":101,"lon":100},[104,105,107],{"name":80,"role":85,"phone":86,"phoneExt":43,"email":87},{"name":106,"role":82,"phone":43,"phoneExt":43,"email":43},"Martin Dichgans, Prof. Dr.",{"name":80,"role":108,"phone":43,"phoneExt":43,"email":43},"SUB_INVESTIGATOR",{"facility":110,"status":111,"city":112,"state":43,"zip":43,"country":95,"countryCode":96,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Charité Universitätsmedizin","RECRUITING","Berlin",{"type":98,"coordinates":114},[115,116],13.41053,52.52437,{"lat":116,"lon":115},[119],{"name":120,"role":85,"phone":121,"phoneExt":43,"email":122},"Matthias Endres, Prof. Dr. med.","+49 30 450 560 102","matthias.endres@charite.de",{"facility":124,"status":111,"city":125,"state":43,"zip":43,"country":95,"countryCode":96,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"University Medical Center Hamburg-Eppendorf","Hamburg",{"type":98,"coordinates":127},[128,129],9.99302,53.55073,{"lat":129,"lon":128},[132],{"name":133,"role":85,"phone":134,"phoneExt":43,"email":135},"Götz Thomalla, Prof. Dr. med.","+49-40-7410-53770","thomalla@uke.de",{"facility":137,"status":111,"city":138,"state":43,"zip":43,"country":95,"countryCode":96,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"MHH Hannover","Hanover",{"type":98,"coordinates":140},[141,142],9.73322,52.37052,{"lat":142,"lon":141},[145],{"name":146,"role":85,"phone":147,"phoneExt":43,"email":148},"Ramona Schuppner, Dr. med.","+49 511-532-2392","Schuppner.Ramona@mh-hannover.de",{"facility":150,"status":91,"city":92,"state":43,"zip":43,"country":95,"countryCode":96,"cosmosGeoPoint":151,"geoPoint":153,"contacts":154},"TUM Klinikum München",{"type":98,"coordinates":152},[100,101],{"lat":101,"lon":100},[155],{"name":156,"role":85,"phone":157,"phoneExt":43,"email":158},"Silke Wunderlich, Prof. Dr. med.","+49 89 4140-5069","silke.wunderlich@tum.de",{"type":82,"investigatorFullName":160,"investigatorTitle":161,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Martin Dichgans","Sponsor-Delegated Person and Principal Investigator",[163,165],{"name":164,"class":6},"University Hospital Erlangen",{"name":166,"class":6},"Universitätsklinikum Hamburg-Eppendorf","100506910","phase-2-reduction-of-systemic-inflammation-after-ischemic-stroke-by-intravenous-dnase-administration-rescind-100506910",false,"NCT05880524","Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)","ReSCInD","Inclusion Criteria:\n\n* Patients with suspected acute ischemic stroke with symptom onset (last-seen-well) until Investigational drug application of less than 12 hours.\n* Consent to participate in the study.\n* Age ≥ 18 years.\n* NIHSS ≥10 at admission.\n\nExclusion Criteria:\n\n* 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.\n* Active malignant tumour disease in the last 6 months.\n* Current known immunosuppression due to immunomodulatory medication with immunosuppressive dose or underlying immunosuppressive disease (e.g. HIV).\n* Acute fulminant infectious disease in the last 7 days (fever \\> 38.5°C or suspected by the Investigator).\n* Breastfeeding or pregnant woman, women of childbearing age without known use of contraceptives with positive urine or serum beta-human choriogonadotropin test.\n* Ischemic stroke or myocardial infarction in the previous 30 days.\n* Surgery in the previous 30 days, except minor dermatological or gynaecological surgery without anaesthesia and wound healing disorders and patients with thrombectomy.\n* Estimated or known weight \\> 100 kg.\n* Known allergies or intolerance to dornase alfa (Pulmozyme) or recombinant protein products derived from Chinese hamster ovary cells.\n* Thrombocytopenia, leukocyte count \\\u003C1500\u002Fμl.\n* Known participation in another clinical trial investigating a drug and\u002For medical product in the last 7 days before study inclusion.\n* Severe renal insufficiency with GFR≤29 ml\u002Fmin\u002F 1.73m³ and\u002For renal insufficiency requiring dialysis.","ALL","18 Years",{"count":177,"type":178},36,"ESTIMATED","INTERVENTIONAL",[181],"PHASE2","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.\n\nParticipants will receive intravenous DNase 1 (500 µg\u002Fkg) 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.",[184,185],"Ischemic Stroke","Inflammatory Response","2026-09-08",{"date":188,"type":189},"2026-09-11","ACTUAL",{"date":191,"type":178},"2026-10-01",{"date":193,"type":178},"2028-07",{"name":5,"class":6},5]