A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/NiaStase®) in Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 554
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.
Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.
详细描述
The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma injury (blunt and/or penetrating) with evidence of active hemorrhage (torso and/or proximal lower extremity) refractory to blood component therapy and surgical haemostatic procedures at the time of randomisation
排除标准
- 未提供
研究组 & 干预措施
rFVIIa, Blunt Trauma
干预措施: eptacog alfa (activated) (Drug)
Placebo, Blunt Trauma
干预措施: placebo (Drug)
rVIIa, Penetrating Trauma
干预措施: eptacog alfa (activated) (Drug)
Placebo, Penetrating Trauma
干预措施: placebo (Drug)
结局指标
主要结局
Mortality
时间窗: from day 0 to 30
Number of participants to die from day 0 to day 30 from all causes.
Morbidity
时间窗: from day 0 to day 30
Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.
次要结局
- Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention(from day 0 to day 30)
- Time to Death From Time of First Dose(from day 0 to day 30)
- Number of Units of Transfused Red Blood Cells From Time of First Dose(from hour 0 to 24)
- Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury(from hour 0 to 24)
- Number of Units of All Allogeneic Transfusions From Time of First Dose(from hour 0 to 24)