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Not yet recruiting NCT06144112

Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery

Phase IV Interventional Liver Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fresh frozen plasma, prothrombin complex concentrate.
Who it may be relevant to
Registry conditions: Liver Diseases. Basic parameters: 20 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Biological fresh frozen plasma
    transfusion of fresh frozen plasma
  • Biological prothrombin complex concentrate
    prothrombin complex concentrate administration

Primary outcome measures

  • intergroup difference in the treatment time (T-time) [Time frame: 1 min]
Secondary outcome measures (9)
  • Red Blood Cell amount [Time frame: 1 hour]
  • FFP amount [Time frame: 1 hour]
  • Platelet amount [Time frame: 1 hour]
  • r-time [Time frame: 1 min]
  • CRT-MA [Time frame: 1 min]
  • CFF-MA [Time frame: 1 min]
  • Bleeding [Time frame: 6 hour]
  • oxygenation profile [Time frame: 1 hour]
  • preparation time of cryoprecipitate or FC [Time frame: 1 min]

Eligibility criteria

Inclusion criteria

  • Liver disease undergoing Liver transplantation

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Samsung Medical Center — Seoul

Publications

  • Bang YJ, Oh CS, Lee DK, Kang H, Kim KW, Kim H, Lee H, Kim TY, Kim GS. Fibrinogen concentrates versus cryoprecipitate for intraoperative hypofibrinogenemia in liver transplantation: study protocol for a randomized trial (FIBCRYO-LT trial). Trials. 2026 Jun 4;27(1):419. doi: 10.1186/s13063-026-09805-1. PMID 42243996

Identifiers

NCT: NCT06144112 · HC22195220002003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗