Anticoagulation After GI Bleeding Pilot Study and Registry (PANTHER-GI)

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: GastroIntestinal Bleeding; Anticoagulant-induced Bleeding

Treatments: Other: Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding; Other: Restart DOAC within 7 days of clinical hemostasis after GI bleeding

Study type: Interventional

Funder types: Other

Identifiers

NCT05290857

3349 20210798-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects aged 18 years or older
2. Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC).
3. OAC therapy discontinued for current acute GI bleed and not yet resumed
4. 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)
5. Planned to resume DOAC post-bleed
6. At moderate to high risk of re-bleeding as per clinical care team
7. Clinical hemostasis achieved as per clinical care team
8. Able and willing to comply with follow-up examinations contained within the consent form

Exclusion criteria

1. Mechanical heart valve
2. VTE in the context of major transient risk factor and completed 3 months of treatment
3. GI bleeding managed surgically (e.g. gastrectomy, colectomy)
4. Active or previously treated gastrointestinal cancer
5. Life expectancy from other causes of less than 3 months
6. Platelet count < 50,000/µL (or < 50x109/L)
7. Renal dysfunction (Creatine Clearance <30 mL/min as calculated by the Cockcroft-Gault formula)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

High thrombotic risk

Experimental group

Description:

For patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis after GI bleeding.

Treatment:

Other: Restart DOAC within 7 days of clinical hemostasis after GI bleeding

Moderate thrombotic risk

Experimental group

Description:

For patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis after GI bleeding.

Treatment:

Other: Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding