Quantra Point-of-Care Hemostasis Monitoring and Perioperative Blood and Blood Component Transfusion During High-Risk Complex Cardiac Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 666
- 试验地点
- 2
- 主要终点
- Blood and blood component transfusions
研究概览
简要总结
The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion).
详细描述
The Investigators propose a randomized control trial to assess patients scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary bypass.
Patients will be randomized 1:1 to routine care or POC Quantra QPlus System. The total number of blood and blood component transfusions (including RBC, plasma, cryoprecipitate, and platelets) during and after cardiac surgery until 12 hours after ICU arrival will be analyzed between the groups.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and outcome assessor will be masked to the group allocation. Clinicians will be unmasked to group allocation.
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
- •Adults aged 18 years or more
- •Scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary bypass (high-risk surgery includes reoperative surgery, active endocarditis, expected need for intraoperative circulatory arrest, radiation heart disease, end-stage kidney disease requiring renal replacement therapy, combination surgery including more than one valve or valve plus CABG, low left ventricular ejection fraction [EF<30%] with potential need for mechanical circulatory support with intra-aortic balloon pump, extracorporeal membrane oxygenation [ECMO], pulmonary thromboembolectomy or percutaneous left ventricular assist device (VAD), and planned placement of a durable left VAD with or without placement of RV assist device.
排除标准
- •Preoperative diagnosis of a pre-existing coagulation or bleeding disorder
- •Preoperative abnormal coagulation disorder (platelet count below 100,000/uL and/or aPTT >40 seconds in the absence of heparin therapy. Prolonged aPTT >40 seconds in the acceptable if due to heparin therapy.)
- •Liver disease, defined as a history of cirrhosis, liver enzymes >3x normal range or manifested by elevated PT suggesting abnormal liver synthetic function not explained by other comorbidities
- •Pregnancy or breastfeeding
- •Refusal to accept red blood cells and blood component transfusions.
- •Contraindications to proposed interventions.
- •Unable to understand English as a first language or unable comprehend the study and/or the consent forms.
- •Vulnerable patients including prisoners, human fetuses, and neonates
研究组 & 干预措施
POC Quantra QPlus System
Perfusion team or trained (certified for POC testing) research personnel will perform hemostasis testing using the Quantra QPlus POC System, results will be interpreted by the primary anesthesia team that will decide if transfusion of blood components is necessary in the operating room and up to 12 hours after surgery in the cardiac surgery intensive care unit (ICU).
干预措施: POC Quantra QPlus System (Device)
Routine Care
The primary anesthesia provider will determine the need for blood and blood component transfusion with or without guidance from central laboratory testing for hemostatic abnormalities in the operating room and up to 12 hours after surgery in the cardiac surgery intensive care unit (ICU).
干预措施: Routine care (Other)
结局指标
主要结局
Blood and blood component transfusions
时间窗: 12 hours after ICU arrival
The total number of blood and blood component transfusions (including RBC, plasma, cryoprecipitate, and platelets) during and after cardiac surgery until 12 hours after ICU arrival.
次要结局
- Bleeding(During hospitalization, up to 24 hours)