Overview
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.
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 timeframe for resuming DOACs will be determined based on the patient's underlying thrombotic risk.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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)
