Effect of Recombinant Coagulation Factor VIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn Excision and Grafting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
研究概览
简要总结
The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower the amount of blood lost during burn surgery.
详细描述
To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned patients, determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area, determine the efficacy of the drug in burned patients undergoing excision of burn wounds.
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
- Triple (Participant, Care Provider, 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
- •Male or female
- •Burn wounds
- •18-65 years of age
- •Scheduled excision of burn wound of at least 20 percent TBSA
排除标准
- •Age greater than 65 years
- •History of blood coagulation disorders
- •Taking anti-coagulation medication
- •Contraindication for heparin therapy
- •Pregnant or nursing females
- •Unstable angina
- •MI within the last 6 months
- •Recent of diagnosis of DVT, stroke within the last 6 months
- •Renal failure requiring dialysis or creatinine clearance less than 25 ml/min
- •Religious prohibition to blood transfusion
- •Have received rFVIIa during current hospitalization
- •Previous enrollment in this study
研究组 & 干预措施
rFVIIa
intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery)
干预措施: Recombinant Factor VIIa (Drug)
Control
intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)
干预措施: Placebo (Drug)
结局指标
主要结局
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
时间窗: 24 hours
次要结局
未报告次要终点