A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Percentage of patients requiring transfusion of packed red blood cells during the procedure
研究概览
简要总结
Objective:
- To evaluate the efficacy of preoperative administration of fibrinogen in liver transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared with placebo, reflecting a reduction in the number of RBC units transfused during the procedure.
- To determine the influence of fibrinogen administration on mortality and survival of liver graft evaluated one year after the procedure.
- To determine the safety of fibrinogen administration recording thrombotic complications evaluated during hospitalization or at least 30 days postoperatively.
详细描述
Methods: A multicenter, randomized, double-blind, placebo-controlled study. One hundred thirty two patients (132) will randomly be assigned to:
Treatment group, Fibrinogen administration; doses of fibrinogen: 1 g for an increase in the plasmatic value of fibrinogen of 0.29 g / L to obtain a value of 2.9 g / L.
Placebo group, to whom the same dose volume of saline will be administered.
Determinations of haematocrit, electrolytes and kidney function tests and coagulation and haemostasis and thrombelastography test are made at all stages of the proceeding. A standard protocol for intraoperative management will be applied. Blood loss, administration of blood products, fluid therapy, presence of reperfusion syndrome, operative complications and mortality and survival will be registered. Patients will be followed for one year after transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients candidates for liver transplantation
- •Patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / L.
排除标准
- •Patients with a value of fibrinogen in the 24 hours prior to the intervention than 2.9 g / L.
- •Known history of thromboembolic events in 30 days
- •Known or suspected pregnancy
- •Previous randomization in this trial
- •Known or suspected allergy to trial products or related products
- •Known presence of congenital bleeding disorder. Patients treated with aspirin, warfarin
- •The following indications for transplantation: familial polyneuropathy, acute liver failure, biliary cirrhosis and sclerosing cholangitis, Budd-Chiari syndrome
- •Heart beating donors and living donor
- •Patient reluctant to participate in the trial
研究组 & 干预措施
Intravenous Fibrinogen
Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved.
干预措施: Fibrinogen (Drug)
Saline Serum
the same dose in volume of saline dilution will be administered. The potential dose of fibrinogen required to obtain a final plasmatic reading of 2.9 g / L. will be computed. A serum will contain the corresponding ml of saline dilution
干预措施: Saline (Drug)
结局指标
主要结局
Percentage of patients requiring transfusion of packed red blood cells during the procedure
时间窗: intraoperative
record of number of red blood cell packeds transfused during the surgical procedure
次要结局
- Percentage of patients requiring blood products other than red cell concentrates(intraoperative)
- Operative outcome(4 weeks)
- liver transplantation outcome(1 year)
研究者
Antoni Sabate
Head of Anesthesiology
Hospital Universitari de Bellvitge