A Multi-center, Randomized, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients

Novo Nordisk A/S43 个研究点分布在 1 个国家开始时间: 2006年5月最近更新: 2012年6月27日

适应症

试验速览

阶段: 3 期
状态: 撤回
发起方: Novo Nordisk A/S
试验地点: 43
主要终点: Mortality and Morbidity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma

Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.

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 65 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 torso hemorrhage refectory to standard treatment

排除标准

未提供

结局指标

主要结局

Mortality and Morbidity

时间窗: through day 30

次要结局

All cause mortality
Hospital-free days
Number of transfusion units
Days free of renal replacement therapy
ICU-free days
Days free of ventilator support

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

研究点 (43)

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