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临床试验/NCT00359398
NCT00359398终止2 期

Post-operative Administration of Platelet Rich Plasma Sequestered Prior to Cardiopulmonary Bypass Reduces the Coagulopathy Associated With Complex Cardiac Surgery

Royal Brompton & Harefield NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年8月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
30
试验地点
2
主要终点
Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser

研究概览

简要总结

Excessive bleeding is common after cardiac surgery. This may result in patients receiving a blood transfusion or suffering the life-threatening complication of cardiac tamponade. Tamponade is when excessive bleeding compresses the heart and prevents it from pumping properly. A major reason for the bleeding is the damage done to platelets by the cardiopulmonary bypass (CPB) machine. Often patients receive platelets and plasma from blood donors to try to reduce the bleeding post-operatively. The investigators plan to take platelets and plasma from patients before they are damaged. They would then return these 'undamaged' sequestered platelets to the patients after the bypass machine is no longer needed. Therefore, the investigators' primary question is whether platelet sequestration would reduce the bleeding problems that occur following cardiac surgery. They will evaluate bleeding problems using thromboelastography, which provides a comprehensive assessment of both how blood clots form and their strength. If sequestration reduces bleeding problems following cardiac surgery then it may reduce the chance of patients receiving blood products from donors. Although donated blood is thoroughly tested, its use does expose patients to the risk of transfusion errors, blood borne infections and reactions. Avoiding its use would be very desirable.

详细描述

Hypothesis:

Patients undergoing repeat median sternotomy or requiring prolonged cardiopulmonary bypass (CPB) often develop a coagulopathy at the end of surgery. We propose sequestering plasma and platelets from these patients prior to CPB and thus prior to the dilution and platelet damage that occurs with CPB. We hypothesise that if these plasma and platelets are stored properly during CPB, and administered at the end of the operation, they will reduce any coagulopathy and the associated bleeding.

Study population:

Patients undergoing repeat median sternotomy, mitral valve repair, double valve operations, aortic surgery, or combined valve and coronary artery surgery.

Exclusion criteria will include those with anaemia, thrombocytopenia, unstable angina, anti-platelet therapy within the previous seven days, known or symptomatic cerebrovascular disease, known disorders of haemostasis, aprotinin sensitivity and pregnancy.

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 (Participant)

入排标准

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

入选标准

  • Adult patients undergoing cardiac surgery that involves:
  • Repeat median sternotomy
  • Mitral valve repair
  • Double valve operations
  • Combined valve and coronary surgery
  • Anticipated prolonged cardiopulmonary bypass

排除标准

  • Pre-operative anaemia
  • Pre-operative thrombocytopenia
  • Unstable angina
  • Anti-platelet therapy (e.g. aspirin, clopidogrel) within the previous 7 days
  • Known or symptomatic cerebrovascular disease
  • Known disorders of haemostasis
  • Aprotinin sensitivity
  • Pregnancy.

结局指标

主要结局

Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser

时间窗: At end of surgery (usually <1 day)

次要结局

  • Volume of blood lost into chest drains during first 24 post-operative hours(24 hours)
  • Volume of blood product administered during first 24 post-operative hours(24 hours)
  • Length of stay in the intensive care unit (ICU)(Usually < 30 days)
  • ICU mortality(Usually < 30 days)
  • Incidence of surgical re-exploration(Hospital admission (usually < 30 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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