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Completed

NCT Number: NCT04062097

Registration of Idarucizumab for Patients with IntraCranial Hemorrhage

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".

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Key information

Conditions

Intracranial Hemorrhage Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Hemorrhage Infarction Intracranial Hemorrhages Ischemia Ischemic Attack, Transient Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Schön Klinik Bad Aibling SE & Co. KG, Bad Aibling, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dabigatran Etexilate Oral Capsule [Pradaxa]

Drug

Dabigatran is the most frequently used direct thrombin inhibitor in secondary stroke prevention in patients with atrial fibrillation.

Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]

Drug

Idarucizumab is the current standard therapy in patients with intracranial bleeding under anticoagulation with dabigatran.

Vitamin K antagonist

Drug

This drug group includes the active substances phenprocoumon and warfarin.

Primary outcomes

  1. Intra-hospital mortality rate

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

    Intra-hospital mortality rate

Secondary outcomes

  1. Change in National Institutes of Health Stroke Scale (NIHSS)

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

    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.

  2. Intracranial bleeding

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

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

  3. Stroke severity

    Time frame: 72 hours after hospital admission

    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.

  4. Functional status

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

    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.

  5. Mortality rate

    Time frame: 7 and 30 days after index event.

    Mortality rate

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Acronym: RIC-ICH

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2019
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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