Anticoagulation After GI Bleeding Pilot Study and Registry

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Mar 21, 2022

Keywords

ClinConnect Summary

The PANTHER-GI Pilot Study is a research trial that aims to understand how safely patients can start taking a specific type of blood thinner, known as direct oral anticoagulants (DOACs), after experiencing a major gastrointestinal (GI) bleed. This study is particularly focused on patients who are at moderate to high risk of bleeding again or developing blood clots. The goal is to see if a standardized approach to resuming these medications can be done safely. Additionally, there will be a registry to gather information about patients who qualify for the study but choose not to participate, helping researchers understand any barriers to enrollment.

To be eligible for this study, participants must be at least 18 years old and have been hospitalized for a serious non-variceal GI bleed while on blood thinners. They should have stopped their anticoagulant therapy due to the bleeding but still need long-term treatment for conditions like atrial fibrillation (a heart rhythm disorder) or blood clots. Participants will be monitored closely after their bleeding has stopped to ensure it's safe to restart their medications. Importantly, this study includes both men and women, and it is currently recruiting participants. If you or someone you know is interested, discussing with a healthcare provider can provide more personalized information and guidance.

Gender

ALL

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)