The Impact of Miniaturized Extracorporeal Circulation on Thrombin Generation and Postoperative Blood Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative thrombin generation
研究概览
简要总结
Rationale:
Contemporary coronary artery bypass grafting (CABG) continues to be associated with a significant risk of postoperative bleeding. Utilization of miniaturized extracorporeal circulation (miECC) significantly reduces the risk of postoperative bleeding but the underlying mechanisms are poorly understood.
Primary Objective:
To assess the impact of miECC compared to conventional extracorporeal circulation (cECC) on thrombin generation as indicator of the overall haemostatic capacity after CABG.
Secondary Objectives To evaluate the impact of miECC versus cECC on blood loss and transfusion requirement, coagulation and fbrinolysis, inflammatory response, haemodilution and haemolysis, endorgan protection, seasibility and safety
Study design:
Single-center, double-blind, parallel-group randomized controlled trial
Study population:
60 Patients undergoing non-emergent primary isolated CABG with ECC randomized 1:1 to receive either miECC or cECC
详细描述
Blood samples will be obtained at the following time points:
- T0; preoperative after induction of anaesthesia (after insertion of central venous line)
- T1; after weaning of the ECC prior to protaminization
- T2; 10 minutes after full protaminization
- T3; six hours after the end of the ECC
- T4; 1. postoperative day (16-20 hours following end of surgery)
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-emergent CABG with ECC
- •Current use of low-dose acetylsalicylic acid
- •Agreement of eligibility by the multidisciplinary heart team
排除标准
- •Inability to give informed consent
- •Emergent treatment required (< 24 hours)
- •Concomitant cardiac surgery
- •Previous cardiac surgery
- •Severely reduced kidney function (eGFR < 30ml/min/1.73m2 or on dialysis)
- •Severely reduced ejection fraction (EF < 45%)
- •Diagnosis of bleeding disorders
- •Non-aspirin antiplatelet drugs stopped < 5 days preoperatively (Clopidogrel, Prasugrel, Ticagrelor, Ticlopidine)
- •Current use of systemic glucocorticoid therapy
- •Current use of vitamin K antagonists or new oral non-vitamin K anticoagulants
- •Platelet count > 450 or <100 x 109/l prior to surgery
- •Pregnant women or women of child bearing potential without negative pregnancy test
- •Active participant in any other intervention trial
结局指标
主要结局
Postoperative thrombin generation
时间窗: up to 6 hours after CABG
Thrombin generation as a measure of the ability to generate thrombin in platelet poor plasma. Derived from the thrombogram
次要结局
- Postoperative blood loss(up to 24 hours after CABG)
- -In-hospital neurological events (TCI/stroke)(up to 30 days after CABG)
- -Postoperative requirement of renal replacement therapy(up to 30 days after CABG)
- -Length of ICU stay(up to 30 days after CABG)
- -Incidence of infection (requiring antibiotic therapy, wound revision for graft leg infection, superficial or deep sternal wound infection)(up to 30 days after CABG)
- Postoperative transfusion requirement(up to 30 days after CABG)
- Inflammatory response(up to 24 hours after CABG)
- Haemolysis (LDH)(up to 24 hours postoperative)
- Fibrinolysis (Clot lysis, Fibrin D-dimer)(up to 24 hours after CABG)
- Coagulation tests(up to 24 hours after CABG)
- Haemodilution (Nadir intraoperative haematocrit)(up to 24 hours after CABG)
- Postoperative CK-MB for myocardial injury(up to 24 hours after CABG)
- -Intraoperative blood lactate for inadequate tissue perfusion(up to 24 hours after CABG)
- Postoperative creatinine clearance for renal injury(up to 30 days after CABG)
- -Perioperative myocardial infarction(48 hours after CABG)
- -Duration of inotropic support(up to 30 days after CABG)
- -Postoperative re-exploration for bleeding(up to 30 days after CABG)
- -Repeat revascularization(up to 30 days after CABG)
- -Incidence of atrial fibrillation(up to 30 days after CABG)
- -Feasibility of miECC as measured by conversion to cECC and intraoperative complications(24 hours)
- -30-day MACCE(up to 30 days after CABG)
- Acute kidney injury(up to 7 days after intervention)
研究者
Ivy susanne Modrau, MD
Consultant Cardiac Surgeon, Associate Professor
Aarhus University Hospital Skejby