Impact of Retrograde Autologous Priming on the Coagulation Profile Assessed by Rotation Thromboelastometry (ROTEM) in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Maximal Clot firmness (MCF) of Externally activated ROTEM assay (EXTEM)
研究概览
简要总结
Cardiac surgery with cardiopulmonary bypass (CPB) is associated with an increased risk of blood transfusions. The primary setup of the CPB circuit demands a priming volume of approximately 1600 mL of crystalloid solution which leads to a relevant hemodilution. The retrograde autologous priming (RAP) procedure minimizes hemodilution by displacing the crystalloid priming volume of arterial and venous lines via passive exsanguination of native blood prior to CPB initiation, resulting in higher hematocrits and reduction of red blood cell transfusion. RAP can also minimize the dilution of coagulation factors as well as red blood cells. Thus, the investigators hypothesized that RAP could maintain better coagulatory function after CPB. In this study, the investigators investigate the impact of RAP on the coagulation profile assessed by rotation thromboelastometry (ROTEM) in participants undergoing cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
One investigator (Anesthesiologist) conducts randomized group assignment. The day of surgery, the researcher informs to surgeon, perfusionist about patient's group assignment.
But, other researcher (ROTEM test), postoperative management do not know the patient's group assignment.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 20 years of age undergoing cardiac surgery / vascular surgery using CPB
排除标准
- •Emergency operation
- •Hemoglobin concentration above 15g/dL
- •Anticoagulants such as warfarin within 5 days before surgery, non-vitamin K antagonist oral
- •anticoagulant within 2 days, and aspirin / clopidogrel / ticagrelor within 5 days
- •Weight less than 45kg, more than 90kg
- •Patients with autoimmune disease
- •Patients who participated in other clinical studies that could affect prognosis
- •Patients who cannot understand the informed consent (eg. Foreigner)
结局指标
主要结局
Maximal Clot firmness (MCF) of Externally activated ROTEM assay (EXTEM)
时间窗: 10 minutes after induction of anesthesia
Maximal Clot firmness (MCF) of EXTEM is a ROTEM parameter representing the strength of a clot, the formation of which is triggered by an activator of extrinsic coagulation pathway.
Maximal Clot firmness (MCF) of EXTEM
时间窗: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Maximal Clot firmness (MCF) of EXTEM is a ROTEM parameter representing the strength of a clot, the formation of which is triggered by an activator of extrinsic coagulation pathway. Dosage of heparin and protamine is only affected by patients' real body weight (not by ROTEM results). That is, in each case, the same protamine dosage applies to both groups.
次要结局
- the number of patients who received plasma product transfusion including fresh frozen plasma, cryoprecipitate and platelet concentrate.(postoperative 48 hours for plasma product transfusion)
- Clotting Time (CT)(15 minutes after injection of protamine (after cessation of CPB for reversal of heparin))
- Clot Formation Time (CFT)(15 minutes after injection of protamine (after cessation of CPB for reversal of heparin))
- A10(15 minutes after injection of protamine (after cessation of CPB for reversal of heparin))
- Maximal Clot firmness (MCF)(15 minutes after injection of protamine (after cessation of CPB for reversal of heparin))