临床试验/NCT01563523

NCT01563523已完成2 期

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 the Treatment of Bleeding in Severely Injured Trauma Subjects

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 283 人开始时间: 2002年3月最近更新: 2017年1月13日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 283
试验地点: 1
主要终点: Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused

研究概览研究设计入排标准研究组 & 干预措施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 Africa, Asia, Europe, Oceania and North America. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII given in conjunction with standard therapy in the treatment of massive bleeding in subjects with severe blunt and/or penetrating trauma injury.

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: 16 Years 至 65 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Informed consent obtained from the subject and/or his/her legally authorised representative (LAR) before any trial-related activities
•Injury(ies) due to a blunt and or penetrating trauma
•Receipt of 6 units of PRBC within a 4 hour period following admittance to the trauma centre
•Receipt of 8 units of PRBC upon administration of trial drug

排除标准

•Prehospital cardiac arrest
•Cardiac arrest in the ER or OR
•Gunshot wound to the head
•Glasgow Coma Scale below 8
•Base deficit of above 15 mEq/l or severe acidosis
•Transfusion of 8 units or more of PRBC prior to arrival in trauma centre

研究组 & 干预措施

Activated recombinant human factor VII

Experimental

干预措施: activated recombinant human factor VII (Drug)

Placebo

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused

次要结局

Adverse Events
Changes in coagulation related parameters: APTT (activated partial thromboplastin time), fibrinogen, D-dimers, anti thrombin-III, F1+2 (prothrombin fragment 1+2) and TAT (thrombin anti thrombin complex)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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