Post-Bleed Management of Antithrombotic Therapy After Gastrointestinal Bleeding: Pilot Study and Registry (PANTHER-GI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
This pilot cohort management study will evaluate a protocolized strategy for resuming DOACs after major GI bleeding based on thrombotic risk among patients at moderate to high risk of rebleeding. The timeframe for resuming DOACs will be determined based on the patient's underlying thrombotic risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 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
排除标准
- •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)
结局指标
主要结局
Recruitment rate
时间窗: 18 months
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.
Total recruitment
时间窗: 18 months
Feasibility criterion of achieving recruitment of 85% of the target sample size of 100 patients
次要结局
- eligibility(18 months)
- completion of all required study procedures(18 months)
- adherence(18 months)
- re-hospitalization(90 days)
- net clinical benefit outcome rate(90 days)
- Quality of life of Panther GI Research participants(90 days)
- major bleeding(90 days)
- acute ischemic stroke, transient ischemic attack or systemic embolism(90 days)
- functional status(90 days)
- consent(18 months)
- repeat endoscopy(90 days)
- all-cause mortality(90 days)
- acute symptomatic VTE(90 days)
- clinically relevant non-major bleeding(90 days)