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Anticoagulant
Timing for Restarting DOACs After Gastrointestinal Bleeding (PANTHER-GI Trial)
N/A
Recruiting
Led By Deborah M Siegal, MD MSc
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
OAC therapy discontinued for current acute GI bleed and not yet resumed
Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
PANTHER-GI Trial Summary
This trial will assess the feasibility of a full-scale study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding.
Who is the study for?
This trial is for adults over 18 who were hospitalized with major non-variceal GI bleeding while on blood thinners, have stopped the thinner due to the bleed and haven't restarted it yet. They must need long-term anticoagulation for conditions like atrial fibrillation or VTE and be at risk of re-bleeding. Excluded are those with very low platelets, severe kidney issues, GI cancer history, surgical management of their bleed, short life expectancy from other causes, mechanical heart valve or certain types of VTE.Check my eligibility
What is being tested?
The PANTHER-GI Pilot Study is testing when to safely restart blood thinners (DOACs) after a major gastrointestinal bleed—either within 7 days or between 7 to 14 days after stopping the bleeding. It aims to find out if this can prevent further bleeding and clotting in patients at moderate to high risk.See study design
What are the potential side effects?
Potential side effects may include risks associated with restarting DOACs such as increased chances of new bleeding events or possibly clot-related complications if resumed too late. The exact side effects will depend on individual patient factors.
PANTHER-GI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I stopped my blood thinner due to a recent stomach bleed and haven't restarted it.
Select...
I am hospitalized due to severe GI bleeding while on blood thinners.
PANTHER-GI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recruitment rate
Total recruitment
Secondary outcome measures
Quality of life of Panther GI Research participants
acute ischemic stroke, transient ischemic attack or systemic embolism
acute symptomatic VTE
+11 morePANTHER-GI Trial Design
2Treatment groups
Experimental Treatment
Group I: Moderate thrombotic riskExperimental Treatment1 Intervention
For patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis after GI bleeding.
Group II: High thrombotic riskExperimental Treatment1 Intervention
For patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis after GI bleeding.
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,591 Total Patients Enrolled
Deborah M Siegal, MD MScPrincipal InvestigatorOttawa Hospital Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped my blood thinner due to a recent stomach bleed and haven't restarted it.I plan to restart my blood thinner medication after a bleeding event.I had surgery to stop GI bleeding.I am hospitalized due to severe GI bleeding while on blood thinners.I am 18 years old or older.I need long-term blood thinners for my heart condition or previous blood clots.My kidney function is low (Creatinine Clearance <30 mL/min).My bleeding is under control as confirmed by my healthcare team.I have or had gastrointestinal cancer.You have less than 3 months to live due to other health issues.You have a mechanical heart valve.I had a blood clot due to a temporary major risk and finished 3 months of treatment.
Research Study Groups:
This trial has the following groups:- Group 1: High thrombotic risk
- Group 2: Moderate thrombotic risk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently searching for participants?
"The research posted on clinicaltrials.gov makes it clear that this study is not accepting new patients, with the trial having first been made available to public view on March 1st 2022 and last updated three weeks later. However, there are presently 372 other clinical studies actively enlisting participants at this time."
Answered by AI
What purpose does this clinical trial aim to achieve?
"This 18-month research project will primarily assess the rate of participant recruitment. Secondary metrics in this trial include net clinical benefit outcome, agreement to participate among eligible patients, and eligibility based on initial screening."
Answered by AI
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