Praxbind data collection program after marketing in India
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patients treated with Pradaxa (dabigatran etexilate)capsules with requirement of rapid reversal of theanticoagulant effects of dabigatran
- Registration Number
- CTRI/2018/08/015462
- Lead Sponsor
- Boehringer Ingelheim India Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
1. Patients treated with Pradaxa (dabigatran etexilate)
capsules with requirement of rapid reversal of the
anticoagulant effects of dabigatran:
ï?· For emergency surgery/urgent procedures
(or)
ï?· In life-threatening or uncontrolled bleeding
2. Written informed consent in accordance with
International Conference on Harmonization Good
Clinical Practice (GCP) guidelines and local legislation
and/or regulations.
Exclusion Criteria
Participation in a PraxbindTM clinical trial
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Any suspected ADRs and fatal AEs; with special focus on hypersensitivity and thrombotic <br/ ><br>event, occurred within 7 days after PraxbindTM administration.Timepoint: occurred within 7 days after PraxbindTM administration.
- Secondary Outcome Measures
Name Time Method Percentage of patients who either received PraxbindTM for emergency surgery/urgent <br/ ><br>procedures or in life-threatening or uncontrolled bleeding at the end of 2 years.Timepoint: at the end of 2 years