Liver DiseasesPhase 4NCT06144112
Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery
A Phase 4 study testing fresh frozen plasma and prothrombin complex concentrate in people with Liver Diseases, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- fresh frozen plasma and prothrombin complex concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2025to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Liver disease undergoing Liver transplantation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Medical Center
Seoul
Yu Jeong Bang, MD, PhD, +821051758275, gagreflex.bang@gmail.com
About this study
Official title: 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
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.
- Conditions
- Liver Diseases
- Being tested
- fresh frozen plasma, prothrombin complex concentrate
- Keywords
- hypofirinogenemia, coagulopathy, fibrinogen, cryoprecipitate, liver transplantation, lyophilized factor concentrates
- Medical subject headings
- Liver Diseases, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fresh frozen plasmaBiological
transfusion of fresh frozen plasma
prothrombin complex concentrateBiological
prothrombin complex concentrate administration
| Study group | Role | What they receive |
|---|---|---|
| cryoprecipitate | Active comparator | If serum-fibrinogen < 100 mg/dl or CFF-MA < 15 mm in thromboelastography (TEG), cryoprecipitate is administered Receives: 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. Receives: Biological: prothrombin complex concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
intergroup difference in the treatment time (T-time)
The treatment time (T-time): the duration from ordering cryoprecipitate or FC to completing its administration
Measured: 1 min
Secondary outcomes (9)
Red Blood Cell amount
Red Blood Cell transfusion amount during surgery
Measured: 1 hour
FFP amount
FFP transfusion amount during surgery
Measured: 1 hour
Platelet amount
Platelet transfusion amount during surgery
Measured: 1 hour
r-time
CK r-time after PCC or FFP
Measured: 1 min
CRT-MA
CRT-MA after PCC or FFP
Measured: 1 min
CFF-MA
CFF-MA after PCC or FFP
Measured: 1 min
Bleeding
Postoperative bleeding amount
Measured: 6 hour
oxygenation profile
PaO2/FiO2 ratio
Measured: 1 hour
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
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Sep 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144112
- Sponsor's protocol ID
- HC22195220002003
- Status last verified
- Jul 2025
- First submitted
- 16 Nov 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing the Time for Managing Intraoperative Hypofibrinogenemia Using Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery (FIBCRYO-LT Trial)
- ClinicalTrials.gov ID
- NCT06144112
- Acronym / sponsor ID
- HC22195220002003
- Conditions
- Liver Diseases
- Keywords
- hypofirinogenemia, coagulopathy, fibrinogen, cryoprecipitate, liver transplantation, lyophilized factor concentrates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Collaborators
- Samsung Medical Center
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cryoprecipitate | Active comparator | Biological: fresh frozen plasmaIf serum-fibrinogen < 100 mg/dl or CFF-MA < 15 mm in thromboelastography (TEG), cryoprecipitate is administered |
| fibirnogen concentrate | Experimental | Biological: prothrombin complex concentrateIf serum-fibrinogen < 80 mg/dl or CFF-MA < 15 mm in thromboelastography (TEG), fibrinogen concentrate is administered. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Liver disease undergoing Liver transplantation
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fresh frozen plasmatransfusion of fresh frozen plasma | Biological | cryoprecipitate |
| prothrombin complex concentrateprothrombin complex concentrate administration | Biological | fibirnogen concentrate |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Derived from this study: PubMed 42243996Bang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fresh frozen plasma and prothrombin complex concentrate in people with Liver Diseases, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tae-Yop Kim, MD PhD (+82-10-8811-6942, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intergroup difference in the treatment time (T-time) (time frame: 1 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.