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临床试验/NCT00188747
NCT00188747已完成4 期

Comparison of Three Management Strategies for Post Cardiac Surgery Coagulopathy.

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2005年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
150
试验地点
2
主要终点
Units of blood products transfused in the first 24 hours post CPB.

研究概览

简要总结

Open-heart surgery frequently results in abnormal clotting, which in turn results in excessive blood loss and the need for transfusion of multiple blood products to patients and leads to adverse outcomes. Prompt identification of any clotting abnormalities after cardiac surgery reduces blood loss and blood product transfusion and may improve outcomes. Currently, however, this monitoring is dependent on standard laboratory-based tests of clotting that have a long turnaround time (30-45 min) and do not measure some important aspect of clotting. There are now other monitoring options that are carried out at patients' bedside, providing results more quickly than standard laboratory tests (within 2-5 minutes for some), and measure more aspects of clotting, providing more information on possible causes of any abnormalities. In this study, we will compare the cost-effectiveness of two of these newer monitoring techniques with standard laboratory-based tests by assigning 150 patients who will be undergoing open-heart surgery to one of the three monitoring techniques (50 patients will be assigned by chance to each group). In each group, an explicit algorithm based on the monitoring technique of that group will be used to guide all transfusion decisions. Between-group differences in number of units of blood products transfused (primary outcome), amount of blood loss, rate of adverse events, and cost of monitoring will be measured. The objective of the study is to determine which of the three methods is most cost-effective in terms of these outcomes.

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
Single

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • greater than 18 years
  • no emergent complex cardiac surgery

排除标准

  • Isolated CABG
  • Single valve surgery
  • Pre-existing coagulopathy PTT>50's, INR>1.3
  • Severe Thrombocytopenia Platelet <100,000
  • Recent Antiplatelet drugs(Plavix within 7 days, Integrilin within 24 hours)

结局指标

主要结局

Units of blood products transfused in the first 24 hours post CPB.

次要结局

  • Test cost, chest tube blood loss 24h; blood products in the postoperative period; modifications in transfusion that would have occurred if result from other group's tests were available; length of stay ICU and hospital; incidence of major complications.

研究者

申办方类型
Other

研究点 (2)

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