Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Change in INR
研究概览
简要总结
Phase 2a study to assess the safety and efficacy of IV infused spray-dried solvent/detergent -treated plasma (Resusix) when compared with an equal volume of plasma frozen within 24 hours after phlebotomy (FP24) in patients with liver disease who are actively bleeding or who require prophylaxis for surgical bleeding
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, Outcomes Assessor)
盲法说明
Single blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SBP 90-150 mm Hg
- •acquired coagulopathy due to hepatic disease
- •INR >1.4
- •Order for 1-4 units of plasma for active bleeding or prophylaxis for bleeding prior to surgery or invasive procedure
- •Written informed consent
- •MELD score: 25 or less (1st cohort), 35 or less (2nd cohort)
排除标准
- •Pregnant women
- •Incarcerated patients
- •Life expectancy less than 72 hours
- •Severe bleeding at time of enrollment
- •HIV, sepsis, intracranial bleeding, congenital disorder, anti-phospholipid antibody syndrome or known lupus anticoagulant antibodies
- •Receipt of plasma products, coagulation factor concentrates or anti-platelets within 3 days of enrollment
- •Specific factor inhibitor activity or history of hypersensitivity to plasma-derived products
- •Receipt of iv heparin within 24 hours of enrollment
- •Use of a continuous infusion of an intravenous vasoactive medication
- •Thrombocytopenia
- •BMI greater than or equal to 40 kg/m2
- •Participation in another clinical trial within 30 days of enrollment and received investigational product that may impact safety or efficacy of this study
- •West Haven Hepatic Encephalopathy Grade 3 or 4 (cohort 1) and Grade 4 (cohort 2)
研究组 & 干预措施
FP24 (Frozen Plasma)
The active comparator FP24 will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period.
干预措施: FP24 (Frozen Plasma) (Biological)
Resusix
The experimental drug (Resusix) will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period.
干预措施: Resusix (Biological)
结局指标
主要结局
Change in INR
时间窗: 120 minutes
Measured as a ratio
Total incidence of all related SAEs
时间窗: 7 days
Count of events
次要结局
- Change in hemoglobin(72 hours)
- Change in activated partial thromboplastin time (aPTT)(72 hours)
- Change in platelet count(72 hours)
- Change in clotting function(72 hours)
- Volume of plasma to correct INR(72 hours)
- Time to INR reduction below 1.5(72 hours)
- Volume of fluid (e.g., crystalloid, colloid, blood component) administered(72 hours)
- Change in bleeding score in patients with active bleeding(120 minutes)
- Thrombin generation(72 hours)
- Serology for human immunodeficiency virus(95 days)
- Serology for hepatitis(95 days)
- Change in Sequential Organ Failure Assessment Score (SOFA)(96 hours)