Registration of Idarucizumab for Patients with IntraCranial Hemorrhage

N/ACompletedNCT04062097

University Hospital, Essen104 enrolled

Overview

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".

Study Type

OBSERVATIONAL

Enrollment

104

Conditions

Intracranial Hemorrhage

Interventions

Dabigatran Etexilate Oral Capsule [Pradaxa]

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (33)

Klinikum Schön Klinik Bad Aibling SE & Co. KG

Bad Aibling, Germany

Hochtaunuskliniken GmbH

Bad Homburg, Germany

Rhön Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, Germany

Vivantes Klinikum Auguste Viktoria

Berlin, Germany

Vivantes Klinikum Neukölln

Berlin, Germany

Vivantes Humboldt Klinikum

Outcomes

Primary Outcomes

Intra-hospital mortality rate

Time frame: From study inclusion until hospital discharge or 30 days after index event, whichever came first.

Secondary Outcomes

Change in National Institutes of Health Stroke Scale (NIHSS)

Change in National Institutes of Health Stroke Scale (NIHSS) of ≥4 pts compared to initial NIHSS or worsening of NIHSS level of consciousness ≥1 point or increase of the volume of the intracranial bleeding or new intraventricular bleeding or death. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

Time frame: At hospital admission, 24 hours after admission and 72 hours after admission.

Intracranial bleeding

Change in size/volume of \> 33% or ≥ 6.5 ml of the intracranial bleeding evaluated by first CT

Time frame: Between 24 and 72 hours after initial CT.

Stroke severity

Change in stroke severity by ≥4 points based on National Institutes of Health Stroke Scale (NIHSS). The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

Time frame: 72 hours after hospital admission

Functional status

Functional status according to modified Rankin Scale (mRS). The scale runs from 0-6, running from perfect health without symptoms to death: 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead.

Time frame: At hospital discharge or 30 days after index event, whichever came first.

Mortality rate

Time frame: 7 and 30 days after index event.