GastroIntestinal Bleeding Clinical Trial
— PANTHER-GIOfficial title:
Post-Bleed Management of Antithrombotic Therapy After Gastrointestinal Bleeding: Pilot Study and Registry (PANTHER-GI)
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Health Services - Peter Lougheed Center Endoscopy Unit | Calgary | Alberta |
Canada | Ottawa Hospital Research Institute | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rate | The pilot study will be considered a success and to have demonstrated feasibility if average recruitment of 2 patients per month at each site is achieved. | 18 months | |
Primary | Total recruitment | Feasibility criterion of achieving recruitment of 85% of the target sample size of 100 patients | 18 months | |
Secondary | eligibility | proportion of patients screened who are eligible to participate out of all patients screened | 18 months | |
Secondary | consent | proportion of eligible patients who provide consent to participate out of all eligible patients | 18 months | |
Secondary | completion of all required study procedures | proportion of patients who complete all required study procedures out of all enrolled patients | 18 months | |
Secondary | adherence | proportion of patients who adhere to study treatment strategy (i.e. resumed DOAC within the specified timeframe) out of the total number of patients enrolled | 18 months | |
Secondary | repeat endoscopy | proportion of patients with repeat endoscopy for suspected bleeding after index GI bleed out of all enrolled patients | 90 days | |
Secondary | re-hospitalization | number of patients re-hospitalization for GI bleeding after index GI bleed out of all patients enrolled | 90 days | |
Secondary | major bleeding | number of patients with major bleeding (as per International Society on Thrombosis and Haemostasis [ISTH] criteria) out of all patients enrolled | 90 days | |
Secondary | clinically relevant non-major bleeding | number of patients with clinically relevant non-major bleeding (CRNMB; as per ISTH) out of all patients enrolled | 90 days | |
Secondary | acute ischemic stroke, transient ischemic attack or systemic embolism | number of patients who experience composite of acute ischemic stroke, transient ischemic attack or systemic embolism our of all patients enrolled | 90 days | |
Secondary | acute symptomatic VTE | number of patients with acute objectively confirmed venous thromboembolism (symptomatic proximal lower extremity deep vein thrombosis [DVT], symptomatic pulmonary embolism [PE] as per ISTH) out of all patients enrolled | 90 days | |
Secondary | net clinical benefit outcome rate | number of patients experiencing composite of stroke, systemic embolic event, major bleeding, or death from any cause out of all patients enrolled | 90 days | |
Secondary | all-cause mortality | number of patients who die of all causes out of all patients enrolled | 90 days | |
Secondary | functional status | Change in functional status measured using Standard Assessment of Global Activities in the Elderly (SAGE) scale at 90 days compared to baseline.
SAGE is a 15-item scale that represents a measure of activities of daily living (ADL) across the spectrum of functioning (cognitive, instrumental and basic ADL). The SAGE is supplemented with additional measures of cognition, mood, and quality of life. The minimum SAGE score - which corresponds to no functional impairments - is 0. The maximum SAGE score - which corresponds to severe global functional impairment - is 45. |
90 days | |
Secondary | Quality of life of Panther GI Research participants | Quality of life measured using EuroQol-5D [EQ-5D®] at 90 days compared to baseline.
The EQ-5D instrument comprises a descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a descriptive profile of a respondent's health state representing the level of reported problems on each of the five dimensions of health (mobility, self-care, usual activities, pain or discomfort, anxiety/depression) that can be converted into a single index value. Average index values (expressed as mean and standard deviation or median and interquartile range depending on skewness) at 90 days will be compared to baseline. The EQ VAS elicits an individual's rating of their own overall current health (0-100 scale where 0 is the worst health you can imagine and 100 is best health you can imagine). Average EQ VAS ratings (expressed as mean and standard deviation or median and interquartile range depending on skewness) at 90 days will be compared to baseline. |
90 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05060731 -
Iron Supplementation in Upper Non-variceal Gastrointestinal Bleeding
|
Phase 4 | |
Recruiting |
NCT05949268 -
Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel
|
||
Not yet recruiting |
NCT03243240 -
Computed Tomography in Gastrointestinal Bleeding
|
N/A | |
Completed |
NCT02595853 -
Efficacy of a Novel Hemostatic Powder in GI Bleeding
|
||
Completed |
NCT01434108 -
Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding
|
Phase 2/Phase 3 | |
Terminated |
NCT01756690 -
Predicting Lung Injury From Transfusion in Patients With Liver Disease
|
N/A | |
Completed |
NCT01424254 -
The Effectiveness of Video-capsule Endoscopy in Gastrointestinal Bleeding of Obscure Origin
|
Phase 3 | |
Completed |
NCT05884931 -
Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment
|
N/A | |
Completed |
NCT01335516 -
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
|
N/A | |
Withdrawn |
NCT00401908 -
Factors Contributing To Cardiovascular Morbidity and Mortality in Patients With Gastrointestinal Bleeding
|
N/A | |
Recruiting |
NCT05024864 -
HELicobacter Pylori Screening to Prevent Gastrointestinal Bleeding in MI Patients
|
N/A | |
Completed |
NCT05008640 -
Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™
|
||
Recruiting |
NCT06259292 -
Comprehensive HHT Outcomes Registry of the United States (CHORUS)
|
||
Completed |
NCT03716466 -
Evaluation of Prophylactic Endotracheal Intubation
|
||
Completed |
NCT05362227 -
High-Volume Vs Low-Volume Preparation in Emergency Department
|
N/A | |
Completed |
NCT02405286 -
Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage
|
N/A | |
Recruiting |
NCT00562445 -
Adrenal Insufficiency in Critical Emergencies in Digestive Diseases
|
N/A | |
Recruiting |
NCT02863250 -
Australian and New Zealand Massive Transfusion Registry
|
||
Completed |
NCT01415869 -
Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
|
||
Completed |
NCT01821326 -
Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding
|
N/A |