Registration of Idarucizumab for Patients with IntraCranial Hemorrhage
- Conditions
- Intracranial Hemorrhage
- Interventions
- Registration Number
- NCT04062097
- Lead Sponsor
- University Hospital, Essen
- Brief Summary
This multicenter, prospective, observational, non-interventional study investigates patients with intracranial hemorrhage under effective anticoagulation with dabigatran or vitamin-K antagonist (VKA). Routine data will be collected during hospitalization. Patients aged 18 years or older under effective therapy with dabigatran and symptomatic intracranial bleeding confirmed by cerebral imaging and treated with idarucizumab will be compared to patients under effective treatment with VKA at the time of onset of the intracranial bleeding. Ninety-five dabigatran patients who provided written informed consent for data transmission will be included. As control group retrospective and anonymized data of 285 VKA patients patients under VKA treatment and admitted to RIC-ICH study centers will be used. For each patient receiving idarucizumab, three patients with intracranial hemorrhage under effective treatment with VKA, will be included (retrospective) in the study. In addition, data of VKA patients will be transferred from the RASUNOA-PRIME and the "Erlanger Hirnblutungs-Register".
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description dabigatran-group Dabigatran Etexilate Oral Capsule [Pradaxa] Patients with the anticoagulating therapy dabigatran and onset of clinically symptomatic intracranial hemorrhage, that is treated with idarucizumab. dabigatran-group Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND] Patients with the anticoagulating therapy dabigatran and onset of clinically symptomatic intracranial hemorrhage, that is treated with idarucizumab. VKA-group Vitamin K antagonist Patients under effective treatment with VKA and with intracranial hemorrhage.
- Primary Outcome Measures
Name Time Method Intra-hospital mortality rate From study inclusion until hospital discharge or 30 days after index event, whichever came first. Intra-hospital mortality rate
- Secondary Outcome Measures
Name Time Method Intracranial bleeding Between 24 and 72 hours after initial CT. Change in size/volume of \> 33% or ≥ 6.5 ml of the intracranial bleeding evaluated by first CT
Functional status At hospital discharge or 30 days after index event, whichever came first. Functional status according to modified Rankin Scale (mRS). The scale runs from 0-6, running from perfect health without symptoms to death: 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead.
Change in National Institutes of Health Stroke Scale (NIHSS) At hospital admission, 24 hours after admission and 72 hours after admission. Change in National Institutes of Health Stroke Scale (NIHSS) of ≥4 pts compared to initial NIHSS or worsening of NIHSS level of consciousness ≥1 point or increase of the volume of the intracranial bleeding or new intraventricular bleeding or death. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Mortality rate 7 and 30 days after index event. Mortality rate
Stroke severity 72 hours after hospital admission Change in stroke severity by ≥4 points based on National Institutes of Health Stroke Scale (NIHSS). The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Trial Locations
- Locations (33)
Klinikum Schön Klinik Bad Aibling SE & Co. KG
🇩🇪Bad Aibling, Germany
Hochtaunuskliniken GmbH
🇩🇪Bad Homburg, Germany
Rhön Klinikum Campus Bad Neustadt
🇩🇪Bad Neustadt An Der Saale, Germany
Vivantes Klinikum Auguste Viktoria
🇩🇪Berlin, Germany
Vivantes Klinikum Neukölln
🇩🇪Berlin, Germany
Vivantes Humboldt Klinikum
🇩🇪Berlin, Germany
Evangelisches Klinikum Bethel gGmbH
🇩🇪Bielefeld, Germany
Universitätsklinkum Bonn
🇩🇪Bonn, Germany
Carl-Thiem-Klinikum Cottbus gGmbH
🇩🇪Cottbus, Germany
Klinikum Allgemeines Krankenhaus Celle
🇩🇪Celle, Germany
SHR Wald-Klinikum Gera GmbH
🇩🇪Gera, Germany
Krankenhaus St. Elisabeth gGmbH
🇩🇪Damme, Germany
Albert-Ludwigs-Universität Freiburg
🇩🇪Freiburg, Germany
Georg-August-Universität Göttingen, Universitätsmedizin
🇩🇪Göttingen, Germany
Klinikum Martha Maria
🇩🇪Halle, Germany
Asklepios Klinik Wandsbek
🇩🇪Hamburg, Germany
Asklepios Klinik Barmbek
🇩🇪Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Klinikum Agatharied GmbH
🇩🇪Hausham, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
BDH-Klinik Hessisch Oldendorf
🇩🇪Hessisch Oldendorf, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Universität Leipzig
🇩🇪Leipzig, Germany
Klinikum Main-Spessart Lohr
🇩🇪Lohr, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
🇩🇪Lübeck, Germany
Universitätsmedizin der Johannes-Guttenberg-Universität Mainz
🇩🇪Mainz, Germany
Klinikum Vest Knappschaftskrankenhaus
🇩🇪Recklinghausen, Germany
Klinikum Osnabrück
🇩🇪Osnabrück, Germany
Klinikum Nordwest Krankenhaus Sande
🇩🇪Sanderbusch, Germany
Klinikum der Landeshauptstadt Stuttgart gKAöR
🇩🇪Stuttgart, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Sana HANSE-Klinikum Wismar GmbH
🇩🇪Wismar, Germany
Katholisches Klinikum Bochum gGmbH, St. Josef Hospital
🇩🇪Bochum, Germany