Praxbind data collection program after marketing in India

Post marketing surveillance program of PraxbindTM use in India

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/08/015462

Enrollment

Registered

2018-08-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients treated with Pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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

Exclusion criteria: Participation in a PraxbindTM clinical trial

Design outcomes

Primary

Measure	Time frame
Any suspected ADRs and fatal AEs; with special focus on hypersensitivity and thrombotic event, occurred within 7 days after PraxbindTM administration.Timepoint: occurred within 7 days after PraxbindTM administration.	—

Secondary

Measure	Time frame
Percentage of patients who either received PraxbindTM for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding at the end of 2 years.Timepoint: at the end of 2 years	—

Countries

India

Contacts

Public ContactPartha Gokhale

Boehringer Ingelheim (India) Pvt Ltd.

partha.gokhale@boehringer-ingelheim.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026