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临床试验/NCT01992757
NCT01992757已完成不适用

Comparison of Thromboelastography-derived Functional Fibrinogen Levels During and After Cardiopulmonary Bypass

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)

研究概览

简要总结

This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Elective cardiac surgery patients who are undergoing primary cardiac surgery

排除标准

  • Emergency surgery
  • Re-operative cardiac surgery
  • History of hypercoagulable state as defined in medical record
  • Anticoagulated status at time of surgery
  • Plasma requirement prior to discontinuation of bypass (alters fibrinogen level)

结局指标

主要结局

Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)

时间窗: Change in FLEV from rewarming and after cardiopulmonary bypass

FLEV values obtained during rewarming while on cardiopulmonary bypass (CPB) were compared to FLEV values obtained immediately after CPB and protamine administration. For all patients included, the mean values for rewarming FLEV and mean values for post-CPB FLEV were obtained. If the mean difference for the two timepoints was not statistically different by t-test, then the primary outcome would demonstrate the value of obtaining a rewarming FLEV sample.

次要结局

  • Difference in Clauss Assay and FLEV(Clauss vs FLEV for rewarming and post-CPB)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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