Status:
RECRUITING
Anticoagulation After GI Bleeding Pilot Study and Registry
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
GastroIntestinal Bleeding
Anticoagulant-induced Bleeding
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) ...
Detailed Description
This pilot cohort management study will evaluate a protocolized strategy for resuming DOACs after major GI bleeding based on thrombotic risk among patients at moderate to high risk of rebleeding. The ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Mechanical heart valve
- VTE in the context of major transient risk factor and completed 3 months of treatment
- GI bleeding managed surgically (e.g. gastrectomy, colectomy)
- Active or previously treated gastrointestinal cancer
- Life expectancy from other causes of less than 3 months
- Platelet count \< 50,000/µL (or \< 50x109/L)
- Renal dysfunction (Creatine Clearance \<30 mL/min as calculated by the Cockcroft-Gault formula)
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05290857
Start Date
March 31 2022
End Date
December 1 2025
Last Update
July 30 2025
Active Locations (2)
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1
Alberta Health Services - Peter Lougheed Center Endoscopy Unit
Calgary, Alberta, Canada, T1Y 6J4
2
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H8L6