MedPath

Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery

Phase 4
Not yet recruiting
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
Inclusion Criteria
  • Liver disease undergoing Liver transplantation
Exclusion Criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
cryoprecipitatefresh frozen plasmaIf serum-fibrinogen \< 100 mg/dl or CFF-MA \< 15 mm in thromboelastography (TEG), cryoprecipitate is administered
fibirnogen concentrateprothrombin complex concentrateIf serum-fibrinogen \< 80 mg/dl or CFF-MA \< 15 mm in thromboelastography (TEG), fibrinogen concentrate is administered.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Red Blood Cell amount1 hour

Red Blood Cell transfusion amount during surgery

r-time1 min

CK r-time after PCC or FFP

CRT-MA1 min

CRT-MA after PCC or FFP

preparation time of cryoprecipitate or FC1 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 amount1 hour

FFP transfusion amount during surgery

Platelet amount1 hour

Platelet transfusion amount during surgery

CFF-MA1 min

CFF-MA after PCC or FFP

Bleeding6 hour

Postoperative bleeding amount

oxygenation profile1 hour

PaO2/FiO2 ratio

Trial Locations

Locations (1)

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Yu Jeong Bang, MD, PhD
Contact
+821051758275
gagreflex.bang@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.