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临床试验/NCT00420667
NCT00420667已完成不适用

Effect of Low Molecular Weight Heparin vs Unfractionated Heparin on Bleeding After Cardiac Surgery

G. d'Annunzio University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2004年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Haematocrit

研究概览

简要总结

Because the impairment of platelet function may cause excess peri-operative bleeding, pre-operative aspirin discontinuation and heparin bridging are common at cardiac surgery. We aimed to evaluate the impact of a low-molecular-weight-heparin (LMWH), enoxaparin, and unfractionated heparin (UFH) on coagulation parameters and peri-operative bleeding in patients undergoing elective coronary artery bypass grafting (CABG) surgery after aspirin discontinuation.

The specific hypothesis of this study was that a 12 h interval is sufficient not to cause excess peri-operative bleeding, and is therefore an optimal compromise between antithrombotic efficacy and haemorrhagic safety.

详细描述

Since LMWH provide many pharmacokinetic advantages compared with UFH, and since they are a valid substitution for UFH in a number of settings, such as non-ST elevation acute coronary syndromes and prevention of venous thromboembolism, LMWH may provide a useful bridge to revascularization after aspirin discontinuation in patients undergoing CABG surgery. Obstacles to the spreading of this practice are mainly the absence of solid evidence of equivalence (or superiority) as to efficacy in this setting, and the proof of equal safety, namely the absence of excess bleeding because some studies have suggested an increased number of haemorrhagic complications after LMWH, particularly with the use of higher doses. This might here be a problem, as patients are here generally at high risk of thrombotic events and for this reason need higher doses than for prevention of venous thromboembolism.

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
None

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 35-75 years with 3-vessel coronary artery disease (CAD)
  • •Candidates to elective CABG

排除标准

  • •Other additional (valve, carotid, etc.) simultaneous surgery required,
  • •Off-pump surgery,
  • •Any altered liver and kidney laboratory parameters,
  • •A history of any haemorrhagic disorders,
  • •Platelet count <100,000 and >450.000/μL,
  • •Treatment with ticlopidine or clopidogrel in the last month.

结局指标

主要结局

Haematocrit

Haemoglobin Concentration

Transfusion Units

Platelet count

次要结局

未报告次要终点

研究者

发起方
G. d'Annunzio University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raffaele De Caterina

Professor

G. d'Annunzio University

研究点 (1)

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