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

University Hospital Essen

Status: Completed

Conditions: Intracranial Hemorrhage

Treatments: Drug: Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]; Drug: Vitamin K antagonist; Drug: Dabigatran Etexilate Oral Capsule [Pradaxa]

Study type: Observational

Funder types: Other

Identifiers

NCT04062097

RIC-ICH

Details and patient eligibility

About

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".

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

104 participants in 2 patient groups

dabigatran-group

Description:

Patients with the anticoagulating therapy dabigatran and onset of clinically symptomatic intracranial hemorrhage, that is treated with idarucizumab.

Treatment:

Drug: Dabigatran Etexilate Oral Capsule [Pradaxa]

Drug: Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]

VKA-group

Description:

Patients under effective treatment with VKA and with intracranial hemorrhage.

Treatment:

Drug: Vitamin K antagonist