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临床试验/NCT00885924
NCT00885924终止4 期

Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
17
试验地点
1
主要终点
Transfusion of blood components

研究概览

简要总结

Some patients undergoing cardiac surgery develop excessive postoperative bleeding. Cardiopulmonary bypass causes platelet dysfunction. Several studies have documented the ability of desmopressin to reduce hemorrhage in a variety of congenital and acquired platelet disorders. In this study the investigators will investigate wether desmopressin reduces postoperative microvascular bleeding. The investigators will investigate wether desmopressin reduces platelet activation as measured by plasma concentration of neutrophil activating peptid 2 and by flow cytometry. The primary endpoint of the study will, however, be total postoperative bleeding and need for transfusions of blood components after surgery. The need for transfusions will be registered during the whole hospital stay. Patient with excessive postoperative bleeding (more than 250 ml for one hour, or more than 150ml for two hours during the first four hours) will be randomized into two groups and given either desmopressin or placebo (0,9% sodium chloride) as an intravenous infusion. Blood samples for plasma concentration measurements will be drawn before infusion of desmopressin/placebo, immediately after the infusion and 20 hours postoperatively. Postoperative bleeding will be registered for 16 hours. The need for any transfusions of blood products will be registered for the whole hospital stay.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Patients above 18 years of age scheduled for cardiac surgery
  • Excessive postoperative bleeding, more than 250 ml for one hour, or more than 150ml for two hours during the first four hours

排除标准

  • Patients younger than 18 years of age
  • Patients with a medical condition known to influence the hemostatic system
  • Patients treated with clopidogrel or systemic steroids during the last week before surgery
  • Patients with INR above 1.5
  • Patients who are not able to give written informed concent
  • Unstable patients who need other transfusion limits than in this study

研究组 & 干预措施

Active treatment

Active Comparator

Desmopressin 0.3 microgram/kg

干预措施: Desmopressin (Drug)

Placebo

Placebo Comparator

NaCl 0.9%

干预措施: Placebo (Drug)

结局指标

主要结局

Transfusion of blood components

时间窗: During postoperative stay

次要结局

  • Postoperative hemorrhage(First 16 hours postoperatively)
  • Platelet activation(20 hours postoperatively)
  • Activation of coagulation(20 hours postoperatively)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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