Clinical trial NCT04062097: Registration of Idarucizumab for Patients with IntraCranial Hemorrhage
Official title: Registration of Idarucizumab for Patients with IntraCranial Hemorrhage (RIC-ICH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Hemorrhage
Keywords: intracranial/intracerebral bleeding
stroke
transient ischemic attack (TIA)
myocardial infarction
anticoagulation
dabigatran
idarucizumab
vitamin-k antagonists
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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".


Eligibility 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.

Primary outcomes:
measure: Intra-hospital mortality rate
timeFrame: From study inclusion until hospital discharge or 30 days after index event, whichever came first.
Secondary outcomes:
measure: Change in National Institutes of Health Stroke Scale (NIHSS)
timeFrame: At hospital admission, 24 hours after admission and 72 hours after admission.
measure: Intracranial bleeding
timeFrame: Between 24 and 72 hours after initial CT.
measure: Stroke severity
timeFrame: 72 hours after hospital admission
measure: Functional status
timeFrame: At hospital discharge or 30 days after index event, whichever came first.
measure: Mortality rate
timeFrame: 7 and 30 days after index event.
Other outcomes:
Locations:
city: Bad Aibling
country: Germany
facility: Klinikum Schön Klinik Bad Aibling SE & Co. KG
city: Bad Homburg
country: Germany
facility: Hochtaunuskliniken GmbH
city: Bad Neustadt An Der Saale
country: Germany
facility: Rhön Klinikum Campus Bad Neustadt
city: Berlin
country: Germany
facility: Vivantes Klinikum Auguste Viktoria
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Vivantes Humboldt Klinikum
city: Bielefeld
country: Germany
facility: Evangelisches Klinikum Bethel gGmbH
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum gGmbH, St. Josef Hospital
city: Bonn
country: Germany
facility: Universitätsklinkum Bonn
city: Celle
country: Germany
facility: Klinikum Allgemeines Krankenhaus Celle
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum Cottbus gGmbH
city: Damme
country: Germany
facility: Krankenhaus St. Elisabeth gGmbH
city: Freiburg
country: Germany
facility: Albert-Ludwigs-Universität Freiburg
city: Gera
country: Germany
facility: SHR Wald-Klinikum Gera GmbH
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen, Universitätsmedizin
city: Halle
country: Germany
facility: Klinikum Martha Maria
city: Hamburg
country: Germany
facility: Asklepios Klinik Wandsbek
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hausham
country: Germany
facility: Klinikum Agatharied GmbH
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Hessisch Oldendorf
country: Germany
facility: BDH-Klinik Hessisch Oldendorf
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Lohr
country: Germany
facility: Klinikum Main-Spessart Lohr
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes-Guttenberg-Universität Mainz
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück
city: Recklinghausen
country: Germany
facility: Klinikum Vest Knappschaftskrankenhaus
city: Sanderbusch
country: Germany
facility: Klinikum Nordwest Krankenhaus Sande
city: Stuttgart
country: Germany
facility: Klinikum der Landeshauptstadt Stuttgart gKAöR
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Wismar
country: Germany
facility: Sana HANSE-Klinikum Wismar GmbH
Study officials:
affiliation: University Hospital, Essen
name: Hans Diener, Prof. Dr.
role: STUDY_DIRECTOR
References: