Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery

NCT ID: NCT06144112

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Liver Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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cryoprecipitate

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

Group Type ACTIVE_COMPARATOR

fresh frozen plasma

Intervention Type BIOLOGICAL

transfusion of fresh frozen plasma

fibirnogen concentrate

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

Group Type EXPERIMENTAL

prothrombin complex concentrate

Intervention Type BIOLOGICAL

prothrombin complex concentrate administration

Interventions

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fresh frozen plasma

transfusion of fresh frozen plasma

Intervention Type BIOLOGICAL

prothrombin complex concentrate

prothrombin complex concentrate administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Liver disease undergoing Liver transplantation

Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role collaborator

Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Tae-Yop Kim, MD PhD

Role: CONTACT

+82-10-8811-6942

Facility Contacts

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Yu Jeong Bang, MD, PhD

Role: primary

+821051758275

Other Identifiers

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HC22195220002003

Identifier Type: -

Identifier Source: org_study_id

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