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Registration of Idarucizumab for Patients With IntraCranial Hemorrhage — RIC-ICH  

Intracranial Hemorrhage Clinical Trial

Official title:
Registration of Idarucizumab for Patients With IntraCranial Hemorrhage (RIC-ICH)

Clinical Trial 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".

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04062097
Study type Observational
Source University Hospital, Essen
Contact
Status Completed
Phase
Start date September 19, 2019
Completion date December 31, 2021
View Details
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