NCT06144112

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

November 16, 2023

Last Update Submit

July 16, 2025

Conditions

Liver Diseases

Keywords

hypofirinogenemiacoagulopathyfibrinogencryoprecipitateliver transplantationlyophilized factor concentrates

Outcome Measures

Primary Outcomes (1)

  • intergroup difference in the treatment time (T-time)

    The treatment time (T-time): the duration from ordering cryoprecipitate or FC to completing its administration

    1 min

Secondary Outcomes (9)

  • Red Blood Cell amount

    1 hour

  • FFP amount

    1 hour

  • Platelet amount

    1 hour

  • r-time

    1 min

  • CRT-MA

    1 min

  • +4 more secondary outcomes

Study Arms (2)

cryoprecipitate

ACTIVE COMPARATOR

If serum-fibrinogen \< 100 mg/dl or CFF-MA \< 15 mm in thromboelastography (TEG), cryoprecipitate is administered

Biological: fresh frozen plasma

fibirnogen concentrate

EXPERIMENTAL

If serum-fibrinogen \< 80 mg/dl or CFF-MA \< 15 mm in thromboelastography (TEG), fibrinogen concentrate is administered.

Biological: prothrombin complex concentrate

Interventions

fresh frozen plasmaBIOLOGICAL

transfusion of fresh frozen plasma

cryoprecipitate
prothrombin complex concentrateBIOLOGICAL

prothrombin complex concentrate administration

fibirnogen concentrate

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver disease undergoing Liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Liver DiseasesHemostatic Disorders

Interventions

Factor IX

Condition Hierarchy (Ancestors)

Digestive System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Central Study Contacts

Tae-Yop Kim, MD PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

September 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations

KR(1)