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New treatment option for GastroIntestinal Bleeding
Official title Anticoagulation After GI Bleeding Pilot Study and Registry
ClinicalTrials.gov ID: NCT05290857
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people 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...
- Planned to resume DOAC post-bleed
You likely can't join if
- 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)
See the full eligibility criteria
- Male or female people 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.