Trials / Completed
CompletedNCT03343704
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
A Phase III, Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure. The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Idarucizumab | Intravenous |
Timeline
- Start date
- 2018-03-26
- Primary completion
- 2020-07-02
- Completion
- 2020-07-02
- First posted
- 2017-11-17
- Last updated
- 2025-02-25
- Results posted
- 2021-08-20
Locations
13 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03343704. Inclusion in this directory is not an endorsement.