Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery

A Randomized Trial Comparing the Time for Managing Intraoperative Hypofibrinogenemia Using Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery (FIBCRYO-LT Trial)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06144112

Enrollment

Registered

2023-11-22

Start date

2025-09-01

Completion date

2026-03-31

Last updated

2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases

Keywords

hypofirinogenemia, coagulopathy, fibrinogen, cryoprecipitate, liver transplantation, lyophilized factor concentrates

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.

Interventions

BIOLOGICALfresh frozen plasma

transfusion of fresh frozen plasma

BIOLOGICALprothrombin complex concentrate

prothrombin complex concentrate administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Liver disease undergoing Liver transplantation

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
FFP amount	1 hour	FFP transfusion amount during surgery
Platelet amount	1 hour	Platelet 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
Red Blood Cell amount	1 hour	Red Blood Cell transfusion amount during surgery
Bleeding	6 hour	Postoperative bleeding amount
oxygenation profile	1 hour	PaO2/FiO2 ratio
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
CFF-MA	1 min	CFF-MA after PCC or FFP

Countries

South Korea

Contacts

Primary ContactTae-Yop Kim, MD PhD

taeyop@gmail.com+82-10-8811-6942

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026