Factor VIII Inhibitor Bypass Activity (FEIBA) for the Reduction of Transfusion in Cardiac Surgery: A Randomized Double Blind Placebo Controlled Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Volume of blood products transfused (mL)
研究概览
简要总结
The purpose of this pilot study is to evaluate the feasibility of the prophylactic administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to demonstrate the potential role of FEIBA administration in reducing the need for allogeneic transfusion to treat refractory coagulopathy in high risk patients.
详细描述
Factor eight inhibitor bypassing activity (FEIBA) is currently approved for use in this country for the treatment of patients with Hemophilia and inhibitors at a dose of 50-100 units/kg. There is a large body of evidence demonstrating the safety and efficacy of FEIBA for Hemophilia patients with inhibitor and has a theoretical advantage compared to current blood product transfusion methods, as it replenishes multiple depleted factors that are lost with prolonged exposure to CPB.
This pilot study is a single center, randomized, double-blinded, placebo controlled trial assessing the feasibility and safety of factor eight inhibitor bypass activity (FEIBA) in patients undergoing major cardiovascular surgery requiring prolonged CPB. The study population will consist of adult patients undergoing elective cardiac surgery at OHSU. Twelve participants will randomly assigned to receive FEIBA or placebo during their surgical procedure.
Patients will be followed to review for adverse events while in the ICU, and up to four weeks after discharge.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Elective aortic or aortic valve procedures, coronary re-implantation (Bentall) with cardiopulmonary bypass, and/or deep hypothermic circulatory arrest.
- •Written informed consent
排除标准
- •Contraindications to the administration of FIEBA or known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components
- •Disseminated intravascular coagulation (DIC)
- •Acute thrombosis or embolism, including myocardial infarction
- •Pregnant women
- •Decisionally impaired adults
- •Prisoners
- •Expressed unwillingness or are otherwise deemed unable to provide written informed consent.
研究组 & 干预措施
FEIBA
Single dose of commercially available FEIBA
干预措施: FEIBA (Drug)
Normal Saline
Single dose of NaCl 0.9%
干预措施: Normal Saline (Drug)
结局指标
主要结局
Volume of blood products transfused (mL)
时间窗: 30 days
-Cumulative volume of blood products transfused, defined as the volume in mL of packed red blood cells, fresh frozen plasma, and platelets, after the administration of the study drug (mL)
次要结局
- Number of thrombotic or thromboembolic events(30 days)
- Number of patients with post-operative bleeding requiring surgical hemostasis(30 days)
- Duration of post-operative ventilation, ICU and hospital length of stay(30 days)
- Number of deaths(30 days)
研究者
Miriam Treggiari
Clinical Research Director
Oregon Health and Science University