Registration of Idarucizumab for Patients with IntraCranial Hemorrhage
RIC-ICH
1 other identifier
observational
104
1 country
33
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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2019
Typical duration for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2019
CompletedFirst Posted
Study publicly available on registry
August 20, 2019
CompletedStudy Start
First participant enrolled
September 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedDecember 9, 2024
April 1, 2022
2.3 years
August 8, 2019
December 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intra-hospital mortality rate
Intra-hospital mortality rate
From study inclusion until hospital discharge or 30 days after index event, whichever came first.
Secondary Outcomes (5)
Change in National Institutes of Health Stroke Scale (NIHSS)
At hospital admission, 24 hours after admission and 72 hours after admission.
Intracranial bleeding
Between 24 and 72 hours after initial CT.
Stroke severity
72 hours after hospital admission
Functional status
At hospital discharge or 30 days after index event, whichever came first.
Mortality rate
7 and 30 days after index event.
Study Arms (2)
dabigatran-group
Patients with the anticoagulating therapy dabigatran and onset of clinically symptomatic intracranial hemorrhage, that is treated with idarucizumab.
VKA-group
Patients under effective treatment with VKA and with intracranial hemorrhage.
Interventions
Dabigatran is the most frequently used direct thrombin inhibitor in secondary stroke prevention in patients with atrial fibrillation.
Idarucizumab is the current standard therapy in patients with intracranial bleeding under anticoagulation with dabigatran.
This drug group includes the active substances phenprocoumon and warfarin.
Eligibility Criteria
Patients with the anticoagulating therapy dabigatran admitted with a clinically symptomatic intracranial bleeding will be included in the study, if they have been treated with idarucizumab (dabigatran-group). It is assumed that some of these patients will have been given an antiplatelet drug as co-medication. As reference population, patients with intracranial hemorrhage under effective treatment with VKA (INR ≥ 1,7) treated in the same center will be used (VKA-group). These patients usually have been treated with some antagonist to VKA (or no reversal therapy at all).
You may qualify if:
- Age ≥18 years at enrollment
- 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.
- \- Patients with intracranial hemorrhage under effective anticoagulation treatment with VKA (INR ≥ 1,7) having been initially treated in the past in the study center.
You may not qualify if:
- Additional therapy with PCC, aPCC or factor VII (in patients under dabigatran).
- \- Start of symptoms of initial ICH event \> 24 h before admission to hospital.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Klinikum Schön Klinik Bad Aibling SE & Co. KG
Bad Aibling, 83043, Germany
Hochtaunuskliniken GmbH
Bad Homburg, 61352, Germany
Rhön Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, 97616, Germany
Vivantes Klinikum Auguste Viktoria
Berlin, 12157, Germany
Vivantes Klinikum Neukölln
Berlin, 12351, Germany
Vivantes Humboldt Klinikum
Berlin, 13509, Germany
Evangelisches Klinikum Bethel gGmbH
Bielefeld, 33617, Germany
Katholisches Klinikum Bochum gGmbH, St. Josef Hospital
Bochum, 44791, Germany
Universitätsklinkum Bonn
Bonn, 53127, Germany
Klinikum Allgemeines Krankenhaus Celle
Celle, 29223, Germany
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus, 03048, Germany
Krankenhaus St. Elisabeth gGmbH
Damme, 49401, Germany
Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau, 79106, Germany
SHR Wald-Klinikum Gera GmbH
Gera, 07548, Germany
Georg-August-Universität Göttingen, Universitätsmedizin
Göttingen, 37075, Germany
Klinikum Martha Maria
Halle, 06120, Germany
Asklepios Klinik Wandsbek
Hamburg, 22043, Germany
Asklepios Klinik Barmbek
Hamburg, 22291, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 22307, Germany
Klinikum Agatharied GmbH
Hausham, 83734, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
BDH-Klinik Hessisch Oldendorf
Hessisch Oldendorf, 31840, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Universität Leipzig
Leipzig, 04103, Germany
Klinikum Main-Spessart Lohr
Lohr, 97816, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
Universitätsmedizin der Johannes-Guttenberg-Universität Mainz
Mainz, 55131, Germany
Klinikum Osnabrück
Osnabrück, 49076, Germany
Klinikum Vest Knappschaftskrankenhaus
Recklinghausen, 45657, Germany
Klinikum Nordwest Krankenhaus Sande
Sanderbusch, 26452, Germany
Klinikum der Landeshauptstadt Stuttgart gKAöR
Stuttgart, 70174, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Sana HANSE-Klinikum Wismar GmbH
Wismar, 23966, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hans Diener, Prof. Dr.
University Hospital, Essen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Professor of Clinical Neurosciences
Study Record Dates
First Submitted
August 8, 2019
First Posted
August 20, 2019
Study Start
September 19, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
December 9, 2024
Record last verified: 2022-04