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Trial record 2 of 2 for:    rasunoa prime

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

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ClinicalTrials.gov Identifier: NCT04062097
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Hans Diener, University Hospital, Essen

Tracking Information
First Submitted Date August 8, 2019
First Posted Date August 20, 2019
Last Update Posted Date October 7, 2019
Actual Study Start Date September 19, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 19, 2019)
  • 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.
  • 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
  • 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.
  • 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.
  • Mortality rate [ Time Frame: 7 and 30 days after index event. ]
    Mortality rate
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registration of Idarucizumab for Patients With IntraCranial Hemorrhage
Official Title Registration of Idarucizumab for Patients With IntraCranial Hemorrhage (RIC-ICH)
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".
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).

Condition Intracranial Hemorrhage
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.
  • Drug: Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]
    Idarucizumab is the current standard therapy in patients with intracranial bleeding under anticoagulation with dabigatran.
  • Drug: Vitamin K antagonist
    This drug group includes the active substances phenprocoumon and warfarin.
Study Groups/Cohorts
  • dabigatran-group
    Patients with the anticoagulating therapy dabigatran and onset of clinically symptomatic intracranial hemorrhage, that is treated with idarucizumab.
    Interventions:
    • Drug: Dabigatran Etexilate Oral Capsule [Pradaxa]
    • Drug: Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]
  • VKA-group
    Patients under effective treatment with VKA and with intracranial hemorrhage.
    Intervention: Drug: Vitamin K antagonist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 19, 2019)
380
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hans Diener, Prof. Dr. +49 201 723 ext 6540 hans.diener@uk-essen.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04062097
Other Study ID Numbers RIC-ICH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Prof. Dr. Hans Diener, University Hospital, Essen
Study Sponsor University Hospital, Essen
Collaborators Not Provided
Investigators
Study Director: Hans Diener, Prof. Dr. University Hospital, Essen
PRS Account University Hospital, Essen
Verification Date October 2019