NCT04062097

Registration of Idarucizumab for Patients with IntraCranial Hemorrhage

Registration of Idarucizumab for Patients with IntraCranial Hemorrhage (RIC-ICH)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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".

Conditions

• Intracranial Hemorrhage

Interventions

Type	Name	Description
DRUG	Dabigatran Etexilate Oral Capsule [Pradaxa]	Dabigatran is the most frequently used direct thrombin inhibitor in secondary stroke prevention in patients with atrial fibrillation.
DRUG	Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]	Idarucizumab is the current standard therapy in patients with intracranial bleeding under anticoagulation with dabigatran.
DRUG	Vitamin K antagonist	This drug group includes the active substances phenprocoumon and warfarin.

Timeline

• Start date: 2019-09-19
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-08-20
• Last updated: 2024-12-09

Locations

33 sites across 1 country: Germany