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Registration of Idarucizumab for Patients with IntraCranial Hemorrhage

NCT04062097 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2024-12-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Hans Diener, Prof. Dr. · University Hospital, Essen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04062097 on ClinicalTrials.gov