Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery
- Conditions
- Liver Diseases
- Interventions
- Registration Number
- NCT06144112
- Lead Sponsor
- Konkuk University Medical Center
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 92
- Liver disease undergoing Liver transplantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cryoprecipitate fresh frozen plasma If serum-fibrinogen \< 100 mg/dl or CFF-MA \< 15 mm in thromboelastography (TEG), cryoprecipitate is administered fibirnogen concentrate prothrombin complex concentrate If serum-fibrinogen \< 80 mg/dl or CFF-MA \< 15 mm in thromboelastography (TEG), fibrinogen concentrate is administered.
- Primary Outcome Measures
Name Time Method intergroup difference in the treatment time (T-time) 1 min The treatment time (T-time): the duration from ordering cryoprecipitate or FC to completing its administration
- Secondary Outcome Measures
Name Time Method Red Blood Cell amount 1 hour Red Blood Cell transfusion amount during surgery
r-time 1 min CK r-time after PCC or FFP
CRT-MA 1 min CRT-MA after PCC or FFP
preparation time of cryoprecipitate or FC 1 min time from the start of preparation (ABO-cross matching and thawing of cryoprecipitate or unpacking FC from its storage) to the delivery to patients in the operation theater
FFP amount 1 hour FFP transfusion amount during surgery
Platelet amount 1 hour Platelet transfusion amount during surgery
CFF-MA 1 min CFF-MA after PCC or FFP
Bleeding 6 hour Postoperative bleeding amount
oxygenation profile 1 hour PaO2/FiO2 ratio
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center🇰🇷Seoul, Korea, Republic ofYu Jeong Bang, MD, PhDContact+821051758275gagreflex.bang@gmail.com