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Not yet recruitingNCT06144112Updated Jul 20, 2025

Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery

A Phase 4 interventional study of fresh frozen plasma and prothrombin complex concentrate in Liver Diseases, sponsored by Konkuk University Medical Center. Not yet recruiting at 1 site in South Korea. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Liver Diseases

Keywords

  • hypofirinogenemia
  • coagulopathy
  • fibrinogen
  • cryoprecipitate
  • liver transplantation
  • lyophilized factor concentrates
03

In context

Liver Diseases

824 studies on the registry are indexed under Liver Diseases; 152 are open to participants now.

This study's planned enrollment of 92 is above the median of 52 across 521 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Konkuk University Medical Center is the lead sponsor of 95 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Liver disease undergoing Liver transplantation

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
92 participants (estimated)

Study arms

  • Active comparator
    cryoprecipitate

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

    Biological: fresh frozen plasma

  • 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

Interventions

06

What researchers measure

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

    Time frame: 1 min

Secondary outcomes

  1. Red Blood Cell amount

    Red Blood Cell transfusion amount during surgery

    Time frame: 1 hour

  2. FFP amount

    FFP transfusion amount during surgery

    Time frame: 1 hour

  3. Platelet amount

    Platelet transfusion amount during surgery

    Time frame: 1 hour

  4. r-time

    CK r-time after PCC or FFP

    Time frame: 1 min

  5. CRT-MA

    CRT-MA after PCC or FFP

    Time frame: 1 min

  6. CFF-MA

    CFF-MA after PCC or FFP

    Time frame: 1 min

  7. Bleeding

    Postoperative bleeding amount

    Time frame: 6 hour

  8. oxygenation profile

    PaO2/FiO2 ratio

    Time frame: 1 hour

  9. preparation time of cryoprecipitate or FC

    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

    Time frame: 1 min

07

Study locations

1 site
08

References and documents

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. PubMed 42243996 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06144112
Lead sponsor
Konkuk University Medical Center
Responsible party
Tae-Yop Kim, MD PhD (Professor of Anesthesiology, Konkuk University Medical Center) — Principal investigator
First posted
Nov 22, 2023
Start date
Sep 1, 2025 (estimated)
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Jul 20, 2025

Study contacts

Tae-Yop Kim, MD PhD
Contact
taeyop@gmail.com
+82-10-8811-6942

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Prothrombin complex concentrate

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