跳至主要内容
临床试验/NCT00328133
NCT00328133已完成不适用

The Use of rFVIIa in Trauma Patients: A WTA/AAST Multi-Center Case Registry

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2006年6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
380
试验地点
1

研究概览

简要总结

Trauma surgeons throughout the US have begun using recombinant activated factor VII (rFVIIa) to control severe hemorrhage following injury when traditional measures have failed. Despite promising results from several small studies, there remain several unanswered questions regarding the use of this relatively expensive product in injured patients including:

  • The timing of administration
  • Selection of appropriate patients who are most likely to benefit
  • The effective dose in injured patients
  • The potential need for repeated dosing
  • The need for administration of platelets and correction of acidosis prior to administering the first dose
  • The risks associated with the use of rFVIIa including venous and/or arterial thrombosis
  • The potential for rFVIIa to cause or aggravate post-injury organ failure and/or infectious complications
  • An analysis of cost versus benefit The purpose of this study is to collect a large sample of patients from multiple institutions in order to address the issues listed above. To this end, the Western Trauma Association Foundation is sponsoring a multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled hemorrhage.

详细描述

This is a prospective, multi-center case registry that seeks to combine the collective experience with the use of rFVIIa at UCSF/SFGH with other trauma centers. The study is being conducted under the auspices of the Western Trauma Association and the American Association of the Surgery of Trauma. Both organizations have a long history of successfully completing multi-center studies. The outcomes to be used in this study are: 1) survival, 2) amount of blood products infused before and after rFVIIa, 3) coagulation factors (PTT, INR) before and after, and 4) the surgeon's assessment of hemostasis. Data will also be analyzed to determine the cost effectiveness of rFVIIa when compared with other methods of treating severe hemorrhage, primarily administration of blood products. Finally, the incidence of complications and thrombotic events after drug administration will be evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Coagulopathy treated with rFVIIa

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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