Do Different Heparin Brands Influence Bleeding in Coronary Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Chest tube drainage
研究概览
简要总结
Two heparin brands have been in the market in Canada for several years. Heparin Leo from Leo Pharma and Hepalean from Organon. The former is standardized by B.P (British pharmacopeia) while the latter is standardized by U.S.P (United states pharmacopeia). Previous studies have shown Heparin Leo to have roughly a 10% less efficacy then Hepalean. It has also been demonstrated that more protamine is required to reverse Heparin Leo. It is the investigators' intention to study the post-operative effects of the two brands of heparin and whether one of the two causes less bleeding after bypass surgery.
详细描述
The study protocol attempts not to change the normal protocol for cardiac surgery too much.
The two different brands of heparin-Heparin Leo (Leo pharma) and Hepalean (Organon) are randomized by the float perfusionist using the program research randomizer.A 50 ml syringe is loaded with heparin for the Anesthesiologist and labelled. A 20 ml syringe is loaded with heparin and thenn labelled. It is a double blinded trial with the surgeon and anesthetist not knowing which brand heparin is being used. All cases are isolated Coronary Artery Bypass Grafting (C.A.B.G) with no concomittant conditions. The following are the patients excluded from the trial
- RE-DO
- COMBINATION PROCEDURE
- VALVE REPAIR/REPLACEMENT
- IABP-PRE/INTRA//POST-OP
- CELL SAVER INTRA-OP
- ANEMIA (70 g/L)/BLEEDING DISORDER eg:Jehovah's witness,hemophilia etc.
- USE OF APROTININ
- SMALL ADULT < 50 KG
- AORTIC SURGERY WITH/WITHOUT CIRC ARREST
- EMERGENT PATIENT WITH HEART FAILURE
Heparin will be administered in the trial to elevate the A.C.T-Activated clotting time to 480 s and above and the heparin level to 300u/Kg to intiate cardio-pulmonary bypass (C.P.B). Additional heparin will be given to maintain the above-mentioned levels.
The following data will be studied
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
- Double (Participant, Care Provider)
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
- •Isolated Coronary Artery Bypass Surgery
- •Normal Hematocrit
- •Normal Creatinine
- •Normal Liver function
排除标准
- •Combination procedure
- •Valve repair/replacement
- •IABP-pre/Intra/Post-op
- •Cell saver intra-op
- •Anemia (70 g/L)/Bleeding disorder, e.g.,: Jehovah's witness, hemophilia etc.
- •Use of aprotinin
- •Small adult < 50 kg
- •Aortic surgery with/without circ. arrest
- •Emergent patient with heart failure
研究组 & 干预措施
Heparin
Compare two market brands of Heparin
干预措施: Heparin Leo and Hepalean (Drug)
结局指标
主要结局
Chest tube drainage
时间窗: 24 to 48 hrs
次要结局
- Measured slope with heparin/ACT titration(1 to 7 hrs)
- Amount of heparin used(1 to 7 hrs)
- Amount of Protamine used(1 to 7 hrs)