Clinical trial NCT05290857: Anticoagulation After GI Bleeding Pilot Study and Registry
Official title: Post-Bleed Management of Antithrombotic Therapy After Gastrointestinal Bleeding: Pilot Study and Registry (PANTHER-GI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GastroIntestinal Bleeding
Anticoagulant-induced Bleeding
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, multicenter, cohort management study and parallel registry
Primary purpose: TREATMENT

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) 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.

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 timeframe for resuming DOACs will be determined based on the patient's underlying thrombotic risk.

Eligibility criteria: 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)

Primary outcomes:
measure: Recruitment rate
timeFrame: 18 months
measure: Total recruitment
timeFrame: 18 months
Secondary outcomes:
measure: eligibility
timeFrame: 18 months
measure: consent
timeFrame: 18 months
measure: completion of all required study procedures
timeFrame: 18 months
measure: adherence
timeFrame: 18 months
measure: repeat endoscopy
timeFrame: 90 days
measure: re-hospitalization
timeFrame: 90 days
measure: major bleeding
timeFrame: 90 days
measure: clinically relevant non-major bleeding
timeFrame: 90 days
measure: acute ischemic stroke, transient ischemic attack or systemic embolism
timeFrame: 90 days
measure: acute symptomatic VTE
timeFrame: 90 days
measure: net clinical benefit outcome rate
timeFrame: 90 days
measure: all-cause mortality
timeFrame: 90 days
measure: functional status
timeFrame: 90 days
measure: Quality of life of Panther GI Research participants
timeFrame: 90 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services - Peter Lougheed Center Endoscopy Unit
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Deborah M Siegal, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: