Post-Bleed Management of Antithrombotic Therapy After Gastrointestinal Bleeding: Pilot Study and Registry (PANTHER-GI)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

PANTHER-GI Pilot Study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding among patients at moderate to high risk of re-bleeding and thrombosis. A parallel registry will assess whether eligible patients who are not enrolled in the PANTHER-GI Pilot Study are systematically different than enrolled patients and to explore barriers to enrolment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female subjects aged 18 years or older

• Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC).

• OAC therapy discontinued for current acute GI bleed and not yet resumed

• Ongoing indication for long-term anticoagulation of atrial fibrillation (moderate to high risk of stroke/systemic embolism with CHA2DS2VASc score of 3 or higher) or VTE (as per clinical care team)

• Planned to resume DOAC post-bleed

• At moderate to high risk of re-bleeding as per clinical care team

• Clinical hemostasis achieved as per clinical care team

• Able and willing to comply with follow-up examinations contained within the consent form

Locations
Other Locations
Canada
Alberta Health Services - Peter Lougheed Center Endoscopy Unit
RECRUITING
Calgary
Ottawa Hospital Research Institute
RECRUITING
Ottawa
Contact Information
Primary
Deborah M Siegal, MD
dsiegal@toh.ca
613-737-8899
Time Frame
Start Date: 2022-03-31
Estimated Completion Date: 2025-12
Participants
Target number of participants: 100
Treatments
Experimental: High thrombotic risk
For patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis after GI bleeding.
Experimental: Moderate thrombotic risk
For patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis after GI bleeding.
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov