A Prospective Study of Coronary Artery Bypass Graft and/or Aortic Valve Replacement With Conventional Versus Half Heparin Dose Under Closed and Coated Extra Corporeal Circulation System (MECC) - APPACHES Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Blood loss
研究概览
简要总结
The purpose of this study is to demonstrate superiority on postoperative bleeding from the use of a heparin half dose compared to a conventional dose, under mini-extra corporeal circulation, without increased risk to the patient.
详细描述
Usually management of conventional extra corporeal circulation takes place under a loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds. This empirical approach based on patient weight date from the 1960's and does not take into account materials improvement and different individual sensitivities; several studies have demonstrated than a result at least as effective could be obtained with heparin lower doses, and without increasing thromboembolic morbid events for patients.
Patients are randomly assigned into one of 2 groups one day before surgery. First group receive unfractionated heparin conventional dose during the MECC, second group receive half of the conventional dose. All surgery is performed by the same team and using same equipment. Regular blood tests are carried out before, during and after surgery. Blood loss, transfusion needs, rhythm disorders, stay duration in intensive care and total hospitalization length is finally reported. The follow-up period through the 30th postoperative day.
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)
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
- •single or multiple coronary bypass
- •written and informed consent
- •repair or replacement of artic leaflet
- •platelet suppressive agents stopped since at least 7 days
- •anticoagulants stopped since at least 3 days
排除标准
- •Thoracic surgery antecedent
- •carotid stenosis > 75%
- •Hb < 10,5 g/l
- •chronic hepatic failure
- •thromboembolic antecedent
研究组 & 干预措施
2
Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin low dose (150 UI/Kg).
干预措施: Heparin Low Dose (Drug)
1
Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin Full Dose (300 UI/Kg)
干预措施: Heparin Full Dose (Drug)
结局指标
主要结局
Blood loss
时间窗: Peroperative and postoperative until redon's suction drainage ablation
次要结局
- Blood transfusion(Per & postoperative)
- Use of intropic drugs (posology)(Postoperative)
- Kidney function(urea, creatininemia)(Postoperative)
- Peroperative hemodynamic data(Peroperative)