Reversal of dabigatran anticoagulant effect with idarucizumab

Phase 1

Conditions: Hemorrhage
MedDRA version: 18.0Level: LLTClassification code 10019524Term: HemorrhageSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-004813-41-CZ

Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

- Group A (Bleeding patients)
-- Overt bleeding judged by the physician to require a reversal agent
-- Currently taking dabigatran etexilate
-- At least 18 years of age
-- Written informed consent
- Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or invasive procedure for a condition other than bleeding)
-- Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
-- Current treatment with dabigatran
-- At least 18 years of age
-- Writen Informed consent.
For both groups: A negative local urine pregnancy test must be obtained for women of childbearing potential prior to study drug administration

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

- Group A (Bleeding Patients)
-- Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care.
-- Patients with no clinical signs of bleeding
-- Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
- Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or invasive procedure for a condition other than bleeding)
-- A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
-- Contraindications to study medication including known hypersensitiity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the reversal of the anticoagulant effect of dabigatran in patients after administration of idarucizumab;Secondary Objective: The secondary objectives are the assesment of bleeding, clinical outcomes, safety and pharmacokinetics of dabigatran in the presence of idarucizumab.;Primary end point(s): 1: Reversal of anticoagulant effect of dabigatran<br>;Timepoint(s) of evaluation of this end point: 1: up to 4 hours<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1: Time to cessation of bleeding (for Group A only)<br><br>2: Occurence of major bleeding (for Group B only) intraoperatively and up to 24 hours post-surgery<br><br>3: Minimum unbound sum (free) dabigatran<br><br>4: Duration of reversal<br><br>5: Reversal of dTT or ECT after the first infusion and before the start of the second<br><br>6: Reversal of aPTT<br><br>7: Reversal of TT;Timepoint(s) of evaluation of this end point: 1: up to 4 hours<br><br>2: up to 15 minutes<br><br>3: up to 4 hours<br><br>4: up to 4 hours<br><br>5: up to 24 hours<br><br>6: up to 24 hours<br><br>7: up to 24 hours<br>