Status:
COMPLETED
Registration of Idarucizumab for Patients with IntraCranial Hemorrhage
Lead Sponsor:
University Hospital, Essen
Conditions:
Intracranial Hemorrhage
Eligibility:
All Genders
18+ years
Brief Summary
This multicenter, prospective, observational, non-interventional study investigates patients with intracranial hemorrhage under effective anticoagulation with dabigatran or vitamin-K antagonist (VKA)....
Eligibility Criteria
Inclusion
- Inclusion Criteria (dabigatran-group):
- 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.
- inclusion (signed informed consent) as soon as possible after start of symptoms of initial ICH event, but before discharge.
- Inclusion Criteria (control-group):
- \- 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 (dabigatran-group):
- Additional therapy with PCC, aPCC or factor VII (in patients under dabigatran).
- Exclusion Criteria (all patients):
- \- Start of symptoms of initial ICH event \> 24 h before admission to hospital.
Exclusion
Key Trial Info
Start Date :
September 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04062097
Start Date
September 19 2019
End Date
December 31 2021
Last Update
December 9 2024
Active Locations (33)
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1
Klinikum Schön Klinik Bad Aibling SE & Co. KG
Bad Aibling, Germany, 83043
2
Hochtaunuskliniken GmbH
Bad Homburg, Germany, 61352
3
Rhön Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, Germany, 97616
4
Vivantes Klinikum Auguste Viktoria
Berlin, Germany, 12157