A Phase III case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated wtih dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

Phase 3

Completed

• Conditions: hemorragisce stroke; emergency surgery/procedure + uncontrolled bleeding; 10003184; 10047079

• Registration Number: NL-OMON42113
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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 procedure where adequate hemostasis is required. Emergency is defined as within the next 8 hours.
-- Current treatment with dabigatran
-- At least 18 years of age
-- Writen Informed consent.

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. (patients with hereditary fructose intolerance may react to sorbitol);- Group B (Patients who require emergency surgery or procedure);-- 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. (patients with hereditary fructose intolerance may react to sorbitol)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the primairy endpoint for this study is to demonstrate the reversal of the<br /><br>anticoagulant effect of dabigatran. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary objectives are the assessment of bleeding, safety, and the<br /><br>pharmacokinetics of dabigatran in the presence of idarucizumab. </p><br>