Registration of Idarucizumab for Patients with IntraCranial Hemorrhage
NCT ID: NCT04062097
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
104 participants
OBSERVATIONAL
2019-09-19
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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dabigatran-group
Patients with the anticoagulating therapy dabigatran and onset of clinically symptomatic intracranial hemorrhage, that is treated with idarucizumab.
Dabigatran Etexilate Oral Capsule [Pradaxa]
Dabigatran is the most frequently used direct thrombin inhibitor in secondary stroke prevention in patients with atrial fibrillation.
Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]
Idarucizumab is the current standard therapy in patients with intracranial bleeding under anticoagulation with dabigatran.
VKA-group
Patients under effective treatment with VKA and with intracranial hemorrhage.
Vitamin K antagonist
This drug group includes the active substances phenprocoumon and warfarin.
Interventions
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Dabigatran Etexilate Oral Capsule [Pradaxa]
Dabigatran is the most frequently used direct thrombin inhibitor in secondary stroke prevention in patients with atrial fibrillation.
Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]
Idarucizumab is the current standard therapy in patients with intracranial bleeding under anticoagulation with dabigatran.
Vitamin K antagonist
This drug group includes the active substances phenprocoumon and warfarin.
Eligibility Criteria
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Inclusion Criteria
* Patients willing and able to provide written informed consent for data transmission (exceptions/special cases for patients who are not legally competent to sign informed consent for data transmission).
* Patients with primary intracranial hemorrhage as confirmed with CT.
* Patients under effective anticoagulation treatment with dabigatran at the time of admission (TT\>60 sec. or last intake of medication \<24hours).
* Patients treated with Idarucizumab (2x2.5 g recommended) may still be included the day after the administration of Praxbind, or on the following working day if treatment was carried out on the weekend.
* inclusion (signed informed consent) as soon as possible after start of symptoms of initial ICH event, but before discharge.
\- Patients with intracranial hemorrhage under effective anticoagulation treatment with VKA (INR ≥ 1,7) having been initially treated in the past in the study center.
Exclusion Criteria
\- Start of symptoms of initial ICH event \> 24 h before admission to hospital.
18 Years
ALL
No
Sponsors
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University Hospital, Essen
OTHER
Responsible Party
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Prof. Dr. Hans Diener
Senior Professor of Clinical Neurosciences
Principal Investigators
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Hans Diener, Prof. Dr.
Role: STUDY_DIRECTOR
University Hospital, Essen
Locations
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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
Katholisches Klinikum Bochum gGmbH, St. Josef Hospital
Bochum, , Germany
Universitätsklinkum Bonn
Bonn, , Germany
Klinikum Allgemeines Krankenhaus Celle
Celle, , Germany
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus, , Germany
Krankenhaus St. Elisabeth gGmbH
Damme, , Germany
Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau, , Germany
SHR Wald-Klinikum Gera GmbH
Gera, , 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 Osnabrück
Osnabrück, , Germany
Klinikum Vest Knappschaftskrankenhaus
Recklinghausen, , 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
Countries
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Other Identifiers
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RIC-ICH
Identifier Type: -
Identifier Source: org_study_id