A Randomized Trial Comparing the Time for Managing Intraoperative Hypofibrinogenemia Using Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery (FIBCRYO-LT Trial)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- intergroup difference in the treatment time (T-time)
研究概览
简要总结
We compared the time consumed for goal-directed management of hypofibrinogemia using two strategies during liver transplant (LT) surgery: a conventional cryoprecipitate-based strategy versus a lyophilized fibrinogen concentrate-based strategy
详细描述
The primary outcome is an inter-group comparison of treatment time (T-time, the duration from ordering cryoprecipitate or FC to completing its administration). The secondary measures include comparisons of perioperative bleeding, blood transfusion, coagulation profiles, reoperation, thromboembolic complications, mortality, oxygenation profiles, fibrinolysis phenotypes, and costs for bleeding management and length of hospital stay.
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)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Liver disease undergoing Liver transplantation
排除标准
- 未提供
研究组 & 干预措施
cryoprecipitate
If serum-fibrinogen < 100 mg/dl or CFF-MA < 15 mm in thromboelastography (TEG), cryoprecipitate is administered
干预措施: fresh frozen plasma (Biological)
fibirnogen concentrate
If serum-fibrinogen < 80 mg/dl or CFF-MA < 15 mm in thromboelastography (TEG), fibrinogen concentrate is administered.
干预措施: prothrombin complex concentrate (Biological)
结局指标
主要结局
intergroup difference in the treatment time (T-time)
时间窗: 1 min
The treatment time (T-time): the duration from ordering cryoprecipitate or FC to completing its administration
次要结局
- Red Blood Cell amount(1 hour)
- r-time(1 min)
- CRT-MA(1 min)
- preparation time of cryoprecipitate or FC(1 min)
- FFP amount(1 hour)
- Platelet amount(1 hour)
- CFF-MA(1 min)
- Bleeding(6 hour)
- oxygenation profile(1 hour)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center