Interruptions in the Coagulationsystem in Relation With Cardiac Surgery -A Randomized Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Delta Thrombingeneration
研究概览
简要总结
The purpose of this study is to find the heparinization method, which
- affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis
- gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery.
The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in the Hepcon-group because of the heparinization-method. Therefore there is a potential higher risk for use of bloodproducts postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Elective on-pump coronary artery bypass grafting (CABG) single procedure
- •Elective aortavalve replacement (AVR) (single procedure)
排除标准
- •Emergency procedures
- •Children and youngsters less than 18 years
- •Pregnancy
- •Less than 2 days break with platelet inhibiting drugs (acetylsalicylic acid, NSAID, clopidogrel, serotonin reuptake inhibitors)
- •Less than 2 days break with AC-treatment (warfarin, heparin, coumarin etc)
- •Known coagulopathy
- •Endocarditis
- •Preoperative anaemia
- •Dialysis patients
研究组 & 干预措施
Activated clotting time (ACT) group
heparinization measured as activated clotting time during surgery
干预措施: Activated clotting time versus blood-heparin concentration (Device)
Hepcon group
heparinization measured as heparin concentration in the blood during surgery
干预措施: Activated clotting time versus blood-heparin concentration (Device)
结局指标
主要结局
Delta Thrombingeneration
时间窗: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Postoperative versus preoperative thrombingeneration evaluated by Endogenous Thrombin Potential,peak Thrombin level and Lagtime by using a Thromboscope
次要结局
- peroperative heparine/protaminesulphate ratio(The timeframe is from the first heparin is given to the neutralization with protamine sulfate, average time 4 hours)
- Platelet function(Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.)
- Thromboelastometry(Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.)
- Standard coagulationtests(Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.)
研究者
Jan Jesper Andreasen, Professor, MD, PhD
Professor
Aalborg University Hospital