PraxbindTM India PMS Program

Boehringer Ingelheim

Status: Completed

Conditions: Thromboembolism

Treatments: Drug: PraxbindTM

Study type: Observational

Funder types: Industry

Identifiers

NCT03359889

1321-0023

Details and patient eligibility

About

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 availability in 2 years at selected centres approved by the regulatory authority.

Enrollment: 5 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

-Participation in a PraxbindTM clinical trial

Trial design

5 participants in 1 patient group

patients administered with PraxbindTM

Treatment:

Drug: PraxbindTM