Status:

COMPLETED

PraxbindTM India PMS Program

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Thromboembolism

Eligibility:

All Genders

Brief Summary

This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availabili...

Eligibility Criteria

Inclusion

  • \- Patients treated with Pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran: For emergency surgery/urgent procedures (or) In life-threatening or uncontrolled bleeding
  • \- Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations

Exclusion

  • Participation in a PraxbindTM clinical trial

Key Trial Info

Start Date :

December 26 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 13 2020

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT03359889

Start Date

December 26 2018

End Date

January 13 2020

Last Update

August 25 2023

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Mazumdar Shaw Medical centre

Bangalore, India, 560099

2

Columbia Asia Referral Hospital

Bengaluru, India, 560055

3

Care Hospital

Hyderabad, India, 500034

PraxbindTM India PMS Program | DecenTrialz