NCT05093504终止不适用
Safe & Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D): Prospective, Multicenter, Double-blind, Randomized Study of Apixaban & Rivaroxaban Removal to Reduce Risk of Serious Bleeding in Urgent Cardiac Surgery Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 27
- 主要终点
- Incidence of Perioperative Bleeding
研究概览
简要总结
Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery
详细描述
The Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants (DOACs) Apixaban & Rivaroxaban (STAR-D) study is a prospective, multicenter, double-blind, randomized study that evaluated the DrugSorb™-Antithrombotic Removal (ATR) device for removal of apixaban and rivaroxaban to reduce the likelihood of serious bleeding in patients undergoing urgent cardiothoracic surgery. The objectives were
- To demonstrate reductions in surgical and early post-surgical bleeding with the intraoperative use of DrugSorb-ATR in patients undergoing cardiothoracic surgery ≤36hrs since last apixaban or rivaroxaban dose.
- To demonstrate reductions in apixaban or rivaroxaban blood levels (Δ[DOAC]) with the intraoperative use of DrugSorb-ATR.
- To establish the safety of the intraoperative use of DrugSorb-ATR in the intended population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 age 18 years or older, with documented full, written informed consent
- •Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within 36 hours from last dose of either apixaban or rivaroxaban (*note that patients must be taking apixaban or rivaroxaban for one of the following indications: a) reduction of stroke/systemic embolism in nonvalvular atrial fibrillation, or b) initial or extended treatment of venous thromboembolism)
排除标准
- •>48hrs between last apixaban or rivaroxaban dose and start of CT surgery
- •Patients on low dose apixaban or rivaroxaban for prophylactic indications
- •Heart-lung transplant procedures
- •Procedures for ventricular assist device (i.e., implant or revision of left ventricular assist device [LVAD] or right ventricular assist device [RVAD])
- •Any of the below conditions that pose a known risk for increased bleeding
- •Heparin induced thrombocytopenia
- •Preoperative platelet count <50,000u/L
- •International normalized ratio (INR) greater than or equal to 1.8
- •Prohibited concomitant antithrombotic medications as defined in the study protocol
- •Acute sickle cell crisis
- •Known allergy to device components
- •Active (untreated) systemic infection
- •History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
- •Women with positive pregnancy test during current admission or who are breast-feeding
- •Life expectancy <30 days
- •Inability to comply with requirements of the study protocol
- •Treatment with investigational drug or device within 30 days of current surgery
- •Previous enrollment in this trial
研究组 & 干预措施
Control
Sham Comparator
Standard of care with Sham set-up
干预措施: Sham comparator (Device)
DrugSorb-ATR Intervention
Experimental
Standard of care + DrugSorb-ATR system
干预措施: DrugSorb-ATR system (Device)
结局指标
主要结局
Incidence of Perioperative Bleeding
时间窗: Through the first 48 hours post-operation
Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint
次要结局
- Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban(Through 30 minutes post-CPB)
- Chest Tube Drainage(Through 24 hours post-operation)
- Platelet Transfusions (Volume)(Through to discharge from index hospitalization, on average 1-2 weeks)
- Platelet Transfusions (Units)(Through to discharge from index hospitalization, on average 1-2 weeks)
- Packed Red Blood Cell (PRBC) Transfusions (Volume)(Through to discharge from index hospitalization, on average 1-2 weeks)
- PRBC Transfusions (Units)(Through to discharge from index hospitalization, on average 1-2 weeks)
- Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events(Through the first day post-operation)
- Surgical Re-exploration for Bleeding(Through to discharge from index hospitalization, on average 1-2 weeks)
- Incidence of Fatal Perioperative Bleeding(Through to discharge from index hospitalization, on average 1-2 weeks)
研究者
研究点 (27)
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