Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Estimated Blood Loss
研究概览
简要总结
Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate levels.
The study design is a prospective randomized interventional trial of transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery.
详细描述
Cardiac surgery carries a significant risk of bleeding requiring transfusion of stored blood products and blood transfusion associated with cardiac surgery consumes 20% of the blood supply worldwide. Although transfusion may be life-saving, significant risks of complications such as lung injury or even an increase in mortality are associated with transfusion. Decreasing transfusion requirements during cardiac surgery has the potential to reduce the rate of complications, improve patient outcomes, and reduce cost resulting in increased value for both the patient and the health system as a whole. Collection of autologous blood before cardiopulmonary bypass (CPB) for transfusion after CPB has been shown to be both safe and effective for reducing blood loss during cardiac surgery, but this intervention has not been targeted to a patient population at high risk for bleeding and transfusion. Fresh whole blood has the capacity to restore coagulation system function during profound coagulopathy in a trauma setting or following massive transfusion by an unknown mechanism. One unit of fresh whole blood is able to restore clotting function equivalent to that achieved by 10 units of pooled platelets. Autologous whole blood collection prior to CPB for transfusion post-operatively has been shown to improve coagulation and decrease clot lysis but is not routinely performed because 90% to 95% of patients do not have extensive blood loss and subsequent coagulopathy. Coupling accurate pre-operative bleeding risk prediction with autologous fresh whole blood collection for transfusion after CPB would target an established, low cost, low risk intervention to an at risk patient population who may experience significant benefit.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects aged 18 to 90
- •Able to provide informed consent
- •Willing to accept autologous or allogenic blood transfusion
- •Scheduled for elective cardiac surgery with cardiopulmonary bypass
排除标准
- •Pre-operative administration of allogenic blood bank products in the previous 3 months
- •Hemodynamically unstable defined as a systolic blood pressure less than 90 mmHg with a heart rate greater 100 or requiring intravenous vasopressor medications
- •Significant active infection or sepsis defined by positive blood culture or positive wound culture
- •Hemoglobin less than 7 g/dl
结局指标
主要结局
Estimated Blood Loss
时间窗: Within 24 hours after surgery
Blood loss is estimated as a percent of total estimated blood volume in the first 24 hours after cardiac surgery.
次要结局
- Development of Myocardial Infarction(31 days)
- Number of allogenic transfusions given(31 days)
- Development of Lung injury(31 days)
- ICU length of stay(31 days)
- Development of Post-operative delirium(31 days)
- Development of Acute Kidney Injury(31 days)
- Incident of peri-operative stroke(31 days)
- Detection of New Onset Atrial fibrillation(31 days)
- Evaluation of Vasopressor requirements (2)(31 days)
- Severity of peri-operative stroke(31 days)
- Initiation of renal replacement therapy(31 days)
- Development of Heart failure(31 days)
- Time to extubation(31 days)
- Evaluation of Vasopressor requirements (1)(31 days)
- Change in endothelial function measured by flow mediated dilation of the brachial artery(24 hours after surgery)
