Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery

July 16, 2025 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tae-Yop Kim, MD PhD
  • Phone Number: +82-10-8811-6942
  • Email: taeyop@gmail.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Liver disease undergoing Liver transplantation

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fibirnogen concentrate
If serum-fibrinogen < 80 mg/dl or CFF-MA < 15 mm in thromboelastography (TEG), fibrinogen concentrate is administered.
Biological: prothrombin complex concentrate
prothrombin complex concentrate administration
Active Comparator: cryoprecipitate
If serum-fibrinogen < 100 mg/dl or CFF-MA < 15 mm in thromboelastography (TEG), cryoprecipitate is administered
Biological: fresh frozen plasma
transfusion of fresh frozen plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intergroup difference in the treatment time (T-time)
Time Frame: 1 min
The treatment time (T-time): the duration from ordering cryoprecipitate or FC to completing its administration
1 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet amount
Time Frame: 1 hour
Platelet transfusion amount during surgery
1 hour
Red Blood Cell amount
Time Frame: 1 hour
Red Blood Cell transfusion amount during surgery
1 hour
FFP amount
Time Frame: 1 hour
FFP transfusion amount during surgery
1 hour
Bleeding
Time Frame: 6 hour
Postoperative bleeding amount
6 hour
oxygenation profile
Time Frame: 1 hour
PaO2/FiO2 ratio
1 hour
r-time
Time Frame: 1 min
CK r-time after PCC or FFP
1 min
CRT-MA
Time Frame: 1 min
CRT-MA after PCC or FFP
1 min
CFF-MA
Time Frame: 1 min
CFF-MA after PCC or FFP
1 min
preparation time of cryoprecipitate or FC
Time Frame: 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
1 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Collaborators

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC22195220002003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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