Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery

Phase 4

Not yet recruiting

• Conditions: Liver Diseases
• Interventions: Biological: fresh frozen plasma; Biological: prothrombin complex concentrate

• 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.

Study Timeline

• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-20
• Study Start: 2025-09-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

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

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