Registration of Idarucizumab for Patients With IntraCranial Hemorrhage

Intracranial Hemorrhage Clinical Trial

— RIC-ICH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062097
• Other study ID #: RIC-ICH
• Status: Completed
• Start date: September 19, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhage
• Intracranial Hemorrhages

Intervention

Drug:
• Dabigatran Etexilate Oral Capsule [Pradaxa]
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]
Idarucizumab is the current standard therapy in patients with intracranial bleeding under anticoagulation with dabigatran.
• Vitamin K antagonist
This drug group includes the active substances phenprocoumon and warfarin.

Locations

Country	Name	City	State
Germany	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 Humboldt Klinikum	Berlin
Germany	Vivantes Klinikum Auguste Viktoria	Berlin
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	Evangelisches Klinikum Bethel gGmbH	Bielefeld
Germany	Katholisches Klinikum Bochum gGmbH, St. Josef Hospital	Bochum
Germany	Universitätsklinkum Bonn	Bonn
Germany	Klinikum Allgemeines Krankenhaus Celle	Celle
Germany	Carl-Thiem-Klinikum Cottbus gGmbH	Cottbus
Germany	Krankenhaus St. Elisabeth gGmbH	Damme
Germany	Albert-Ludwigs-Universität Freiburg	Freiburg
Germany	SHR Wald-Klinikum Gera GmbH	Gera
Germany	Georg-August-Universität Göttingen, Universitätsmedizin	Göttingen
Germany	Klinikum Martha Maria	Halle
Germany	Asklepios Klinik Barmbek	Hamburg
Germany	Asklepios Klinik Wandsbek	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Klinikum Agatharied GmbH	Hausham
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	BDH-Klinik Hessisch Oldendorf	Hessisch Oldendorf
Germany	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Germany	Universität Leipzig	Leipzig
Germany	Klinikum Main-Spessart Lohr	Lohr
Germany	Universitätsklinikum Schleswig-Holstein, Campus Lübeck	Lübeck
Germany	Universitätsmedizin der Johannes-Guttenberg-Universität Mainz	Mainz
Germany	Klinikum Osnabrück	Osnabrück
Germany	Klinikum Vest Knappschaftskrankenhaus	Recklinghausen
Germany	Klinikum Nordwest Krankenhaus Sande	Sanderbusch
Germany	Klinikum der Landeshauptstadt Stuttgart gKAöR	Stuttgart
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Sana HANSE-Klinikum Wismar GmbH	Wismar

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-hospital mortality rate	Intra-hospital mortality rate	From study inclusion until hospital discharge or 30 days after index event, whichever came first.
Secondary	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.	At hospital admission, 24 hours after admission and 72 hours after admission.
Secondary	Intracranial bleeding	Change in size/volume of > 33% or = 6.5 ml of the intracranial bleeding evaluated by first CT	Between 24 and 72 hours after initial CT.
Secondary	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.	72 hours after hospital admission
Secondary	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.	At hospital discharge or 30 days after index event, whichever came first.
Secondary	Mortality rate	Mortality rate	7 and 30 days after index event.