NCT01601457已完成2 期
A Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Efficacy and Safety of Activated Recombinant Coagulation Factor VII (rFVIIa, NovoSeven®) in Patients With Major Fractures of Pelvis or Pelvis and Acetabulum Undergoing Repair Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Total volume of perioperative blood loss
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular fractures.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Injury due to a blunt or penetrating trauma causing pelvic or pelvic and acetabular fracture amenable to surgical reconstruction
- •Scheduled for a semi-elective reconstruction surgery for fracture(s) of pelvis or pelvis and acetabulum, which was expected to be a "large" complex procedure with the potential of blood loss more than 50% of circulating blood volume
排除标准
- •A history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis)
- •Patients with severe head injuries or an abnormal computed tomography (CT) scan of the head due to head injuries
- •Body weight exceeding 135 kg
- •Cardiac arrest following trauma and prior to surgery
- •Known congenital bleeding disorders
- •Known pregnancy or positive pregnancy test at enrolment
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
Total volume of perioperative blood loss
次要结局
- Volumes of intraoperative and postoperative blood loss
- Volume of blood transfused during the perioperative period
- Vital signs
- Adverse events
研究者
研究点 (1)
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