Association of Fibrin Clot Properties With Blood Loss Following Coronary Artery By-pass Grafting - Does Surgical Technique of Left Internal Mammary Artery Harvesting Matter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Postoperative chest-tube output after 12 hours
研究概览
简要总结
Up to 15% of operations in cardio-pulmonary by-pass are complicated by excessive postoperative blood loss, which negatively affects the outcomes. Recently, it has been demonstrated that fibrin clot susceptibility to lysis is a modulator of postoperative blood loss after cardiac surgery for aortic stenosis. Earlier, a preliminary study showed a negative association of postoperative blood loss after coronary artery by-pass grafting (CABG) with fibrin clot lysis time, reflecting susceptibility to fibrinolysis.
In CABG, postoperative blood loss may depend on the operative technique with respect to left internal mammary artery (LIMA) harvesting. LIMA is taken down in virtually all CABG procedures, but harvesting technical details remain at surgeons discretion (skeletonization without opening the pleural cavity vs. pedicled graft with pleura wide open).
The investigators decided to test the hypothesis that fibrin clot properties modulate the postoperative drainage following CABG strongly enough to attenuate the influence of surgical technique by randomizing the patients undergoing CABG with regard to LIMA harvesting technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patient will be blinded to LIMA harvesting technique. The laboratory technicians will be blinded to LIMA harvesting technique.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angiographically confirmed coronary artery disease
- •Heart Team qualification for first time elective coronary artery by-pass grafting
- •No significant valvular disease or congenital heart disease
- •Normal sinus rhythm on ECG
- •Continued aspirin in perioperative period
排除标准
- •Need for any concomitant cardiac procedure
- •St. p. percutaneous coronary intervention within preceding 3 months
- •Any previous cardiac surgery
- •Known bleeding diathesis
- •Acute cardiovascular incident within preceding 3 months
- •Heart failure with left ventricular ejection fraction <30%
- •Any autoimmune disease
- •Any acute infection
- •Known neoplasm
- •Any thyroid disease
- •Treatment with any thienopyridine, oral anticoagulant, heparin or any non-steroid anti-inflammatory agent other than aspirin
- •Mental disorder
- •Severe comorbidities (liver failure, renal failure on hemodialysis)
- •Lacking consent
结局指标
主要结局
Postoperative chest-tube output after 12 hours
时间窗: 12 hours from the end of operation
Drainage volume after 12 hours
次要结局
- Perioperative myocardial infarction(48 hours after the procedure)
研究者
Piotr Mazur
Principal Investigator
Jagiellonian University