PraxbindTM India PMS Program

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Mazumdar Shaw Medical centre, Bangalore, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PraxbindTM

Drug

Other names: PRAXBIND, Praxbind, Prizbind

Primary outcomes

Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)

Time frame: Up to 7 days following treatment.

Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration.

Secondary outcomes

Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding

Time frame: Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®.

Percentage of patients who received Praxbind® either for emergency surgery/urgent procedures or for life-threatening or uncontrolled bleeding.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post Marketing Surveillance Program of Praxbind Use in India.

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Dec 2, 2017
Registry last updated: Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed