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Intracranial HemorrhageRIC-ICHNCT04062097

Registration of Idarucizumab for Patients with IntraCranial Hemorrhage

An observational study of Intracranial Hemorrhage, run by University Hospital, Essen at 33 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Hemorrhage
What is being tested?
Dabigatran Etexilate Oral Capsule [Pradaxa], Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND] and Vitamin K antagonist
How many people
104 participants
Where
33 sitesGermany
Study dates
19 Sep 2019to 31 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with the anticoagulating therapy dabigatran admitted with a clinically symptomatic intracranial bleeding will be included in the study, if they have been treated with idarucizumab (dabigatran-group). It is assumed that some of these patients will have been given an antiplatelet drug as co-medication. As reference population, patients with intracranial hemorrhage under effective treatment with VKA (INR ≥ 1,7) treated in the same center will be used (VKA-group). These patients usually have been treated with some antagonist to VKA (or no reversal therapy at all).

Who may be able to join

  • 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.
  • Patients with intracranial hemorrhage under effective anticoagulation treatment with VKA (INR ≥ 1,7) having been initially treated in the past in the study center.

Who cannot join

  • Additional therapy with PCC, aPCC or factor VII (in patients under dabigatran).
  • Start of symptoms of initial ICH event > 24 h before admission to hospital.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Germany33 sites

  • Klinikum Schön Klinik Bad Aibling SE & Co. KG

    Bad Aibling, 83043

  • Hochtaunuskliniken GmbH

    Bad Homburg, 61352

  • Rhön Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale, 97616

  • Vivantes Klinikum Auguste Viktoria

    Berlin, 12157

  • Vivantes Klinikum Neukölln

    Berlin, 12351

  • Vivantes Humboldt Klinikum

    Berlin, 13509

  • Evangelisches Klinikum Bethel gGmbH

    Bielefeld, 33617

  • Katholisches Klinikum Bochum gGmbH, St. Josef Hospital

    Bochum, 44791

  • Universitätsklinkum Bonn

    Bonn, 53127

  • Klinikum Allgemeines Krankenhaus Celle

    Celle, 29223

  • Carl-Thiem-Klinikum Cottbus gGmbH

    Cottbus, 03048

  • Krankenhaus St. Elisabeth gGmbH

    Damme, 49401

  • Albert-Ludwigs-Universität Freiburg

    Freiburg im Breisgau, 79106

  • SHR Wald-Klinikum Gera GmbH

    Gera, 07548

  • Georg-August-Universität Göttingen, Universitätsmedizin

    Göttingen, 37075

  • Klinikum Martha Maria

    Halle, 06120

  • Asklepios Klinik Wandsbek

    Hamburg, 22043

  • Asklepios Klinik Barmbek

    Hamburg, 22291

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 22307

  • Klinikum Agatharied GmbH

    Hausham, 83734

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • BDH-Klinik Hessisch Oldendorf

    Hessisch Oldendorf, 31840

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universität Leipzig

    Leipzig, 04103

  • Klinikum Main-Spessart Lohr

    Lohr, 97816

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538

  • Universitätsmedizin der Johannes-Guttenberg-Universität Mainz

    Mainz, 55131

  • Klinikum Osnabrück

    Osnabrück, 49076

  • Klinikum Vest Knappschaftskrankenhaus

    Recklinghausen, 45657

  • Klinikum Nordwest Krankenhaus Sande

    Sanderbusch, 26452

  • Klinikum der Landeshauptstadt Stuttgart gKAöR

    Stuttgart, 70174

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Sana HANSE-Klinikum Wismar GmbH

    Wismar, 23966

Other trials in Germany

About this study

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

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".

Being tested
Dabigatran Etexilate Oral Capsule [Pradaxa], Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND], Vitamin K antagonist
Keywords
intracranial/intracerebral bleeding, stroke, transient ischemic attack (TIA), myocardial infarction, anticoagulation, dabigatran, idarucizumab, vitamin-k antagonists
Medical subject headings
Intracranial Hemorrhages, Stroke, Ischemic Attack, Transient, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 antagonistDrug

    This drug group includes the active substances phenprocoumon and warfarin.

Study groups in NCT04062097
Study groupRoleWhat they receive
dabigatran-groupPatients with the anticoagulating therapy dabigatran and onset of clinically symptomatic intracranial hemorrhage, that is treated with idarucizumab.
Receives: Drug: Dabigatran Etexilate Oral Capsule [Pradaxa]; Drug: Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]
VKA-groupPatients under effective treatment with VKA and with intracranial hemorrhage.
Receives: Drug: Vitamin K antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intra-hospital mortality rate

    Intra-hospital mortality rate

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

Secondary outcomes (5)

  1. 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.

    Measured: At hospital admission, 24 hours after admission and 72 hours after admission.

  2. Intracranial bleeding

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

    Measured: Between 24 and 72 hours after initial CT.

  3. 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.

    Measured: 72 hours after hospital admission

  4. 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.

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

  5. Mortality rate

    Mortality rate

    Measured: 7 and 30 days after index event.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2019
  2. Study start19 Sep 2019
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04062097
Sponsor's protocol ID
RIC-ICH
Acronym
RIC-ICH
Status last verified
Apr 2022
First submitted
8 Aug 2019
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Hemorrhage, run by University Hospital, Essen at 33 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra-hospital mortality rate (time frame: From study inclusion until hospital discharge or 30 days after index event, whichever came first.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04062097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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