Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Significant postoperative bleeding
研究概览
简要总结
The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.
The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.
详细描述
Studies have shown that materials containing fibrin shorten the time to hemostasis in the case of planned liver resection, but did not show a significant effect on the occurrence of postoperative bleeding. The aim of the study is to supplement knowledge about hemostatic matrices in liver transplantation, which will be used for the inferior vena cava anastomosis.
The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.
The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •age over 18
- •elective liver transplantation
- •informed consent to participate in the study
排除标准
- •decision to use packing during liver transplantation (bail out strategy)
研究组 & 干预措施
Tachosil® used in Vena Cava Inferior anastomosis
Tachosil® used in Vena Cava Inferior anastomosis.
干预措施: TachoSil (Drug)
结局指标
主要结局
Significant postoperative bleeding
时间窗: 10 days
occurrence of significant postoperative bleeding within 10 days after surgery, defined as the occurrence of one of the following: 1. occurrence of hematoma larger than 100ml 2. transfusion of packed red blood cells after surgery 3. performing relaparotomy due to bleeding
次要结局
- Postoperative complication(10 days)
研究者
Paweł Rykowski
MD
Medical University of Warsaw