Anticoagulation After GI Bleeding Pilot Study and Registry

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 31, 2022

Primary Completion Date

July 31, 2025

Study Completion Date

December 31, 2025

Conditions
GastroIntestinal BleedingAnticoagulant-induced Bleeding
Interventions
OTHER

Restart DOAC within 7 days of clinical hemostasis after GI bleeding

"In patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis (as judged by the clinical team).~High thrombotic risk includes the following:~(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 5 or higher (ii) Atrial fibrillation or atrial flutter with CHA2DS2VASc score or 3 to 4 with recent ischemic stroke, TIA or systemic embolism (within 6 months) (iii) VTE (proximal DVT or PE) within 3 months (iv) Recurrent VTE (proximal DVT or PE) (v) VTE (proximal DVT or PE) associated with antiphospholipid syndrome (if eligible for DOAC) (vi) VTE (proximal DVT or PE) associated with active non-GI cancer (vii) None of the above but considered high thrombotic risk as per investigator"

OTHER

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

"In patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis (as judged by the clinical team).~Moderate thrombotic risk includes the following:~(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 3 to 4 (ii) VTE (proximal DVT or PE) beyond 3 months~The type and dose of DOAC will be according to patient and physician choice and will be prescribed by the clinical care team."

Trial Locations (2)

T1Y 6J4

RECRUITING

Alberta Health Services - Peter Lougheed Center Endoscopy Unit, Calgary

K1H8L6

RECRUITING

Ottawa Hospital Research Institute, Ottawa

All Listed Sponsors
lead

Ottawa Hospital Research Institute

OTHER