Liver Transplant SurgeryPhase 4NCT07265843
Fibrinogen in Liver Transplant
A Phase 4 study testing Intercept Fibrinogen Complex (IFC) and Cryoprecipitate Antihemophilic Factor (AHF) in people with Liver Transplant Surgery, run by Trauma Hemostatis and Oxygenation Research (THOR) Network at 1 site in United States.
Trial summary
The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of two approved products Intercept Fibrinogen Complex (IFC) to Standard Cryoprecipitate Antihemophilic Factor (AHF) for liver transplant patients with bleeding… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Surgery
- What is being tested?
- Intercept Fibrinogen Complex (IFC) and Cryoprecipitate Antihemophilic Factor (AHF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2026to 1 Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Scheduled to undergo cadaveric liver transplant
- Meets at least one of the following criteria: Baseline fibrinogen <200 mg/dL or clinically significant visoelastic testing
- Meets any one of the following criteria: Alcoholic cirrhosis, Metabolic dysfunction associated steatohepatitis (MASH) (previously known as Nonalcoholic Steatohepatitis (NASH)), HCV infection
Who cannot join
- Living related donor transplant,
- Known prothrombotic disorder,
- Patient objection to blood transfusion,
- Known severe allergic reaction to plasma-based products,
- IgA deficiency with known hypersensitivity reaction to plasma,
- Hepatocellular/cholangio carcinoma,
- Primary biliary fibrosis
- Active bleeding prior to the operation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45221
Ralph Quillin, 513-558-3993, quillirc@ucmail.uc.edu
About this study
Official title: Fibrinogen in Liver Transplant Subjects (FITS)
The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of two approved products Intercept Fibrinogen Complex (IFC) to Standard Cryoprecipitate Antihemophilic Factor (AHF) for liver transplant patients with bleeding and hypofibrinogenemia to determine impact of earlier access to a concentrated source of fibrinogen in a goal-directed manner.
Read the detailed description
Fibrinogen is an important factor for hemostasis and when it is deficient or dysfunctional replacing it will improve hemostasis and reduce bleeding. Observational data indicates the use of cryoprecipitate as a source of fibrinogen may reduce bleeding and improve outcomes in patients with severe bleeding. Liver transplant patients often become hypofibrinogenemic and may benefit from early goal directed use of cryoprecipitate or IFC. IFC can be more readily available since it can be stored at room temperature compared to cryoprecipitate which requires thawing. As a result, IFC can be immediately available when indicated compared to the delay in administration of cryoprecipitate due to the need for it to be thawed. This trial will compare clinical outcomes for subjects randomized to either cryoprecipitate or IFC in bleeding liver transplant patients with reduced fibrinogen function.
There is no data comparing outcomes for subjects receiving IFC or cryoprecipitate in any patient population.
The rationale for this trial is to compare IFC to cryoprecipitate (cryo) to assist with the design of a future definitive multicenter trial. Potential advantages of IFC are that since it is stored at room temperature it can be made immediately available whereas with cryo the delay in treatment can be 30 to 40 min due to the need to thaw it from a frozen state. The reduced time to treatment of bleeding may improve outcomes with the use of IFC compared to cryo. In vitro data indicates similar hemostatic function between IFC and Cryo. IFC is pathogen reduced cryoprecipitate. The pathogen reduction methods are licensed for IFC and there has been no safety concerns regarding its use at the centers that are currently using it as their standard product (unpublished).
- Conditions
- Liver Transplant Surgery
- Being tested
- Intercept Fibrinogen Complex (IFC), Cryoprecipitate Antihemophilic Factor (AHF)
- Keywords
- Cryoprecipitate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercept Fibrinogen Complex (IFC)Biological
INTERCEPT Fibrinogen Complex is a pathogen-reduced cryoprecipitated fibrinogen complex derived from human plasma. It contains fibrinogen, Factor XIII, and von Willebrand factor to achieve stable clot formation and restore hemostasis. Recently approved by the US Food and Drug Administration, it is used for the treatment of bleeding associated with fibrinogen deficiency.
Cryoprecipitate Antihemophilic Factor (AHF)Biological
Cryoprecipitate Antihemophilic Factor (AHF), also known as cryo, is a frozen blood product prepared from blood plasma. It is used for fibrinogen supplementation, particularly for hypofibrinogenemia fibrinogen, anemia associated with bleeding or congenital deficiency.
| Study group | Role | What they receive |
|---|---|---|
| Standard Antihemophilic Factor (AHF) | Active comparator | AHF is the standard of care fibrinogen product often used in liver transplant cases. The procedures to use AHF include requesting the order of this product and then waiting for the product to be thawed for use, which can take approximately 10-15 minutes. Subjects assigned to this group will receive all standard of care procedures, including the use of AHF if required during their scheduled surgery. Receives: Biological: Cryoprecipitate Antihemophilic Factor (AHF) |
| Intercept Fibrinogen Complex (IFC) | Active comparator | IFC is an approved fibrinogen product that is not typically stored in the OR for liver transplant cases. Subjects assigned to this group will receive standard of care procedures, with the addition of IFC being readily available in their designated OR to eliminate any delay if they are to require the use of a fibrinogen product. Receives: Biological: Intercept Fibrinogen Complex (IFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood products (24-hours) [Time Frame: 24-hours after initial blood product administration]
The amount of blood products (mL) administered will be collected at the 24-hour timepoint per intervention group and reported as the mean (mL).
Measured: 24-hour
Secondary outcomes (3)
Change in Visoelastic parameters [Time Frame: pre-intervention through 24 hours post intervention]
Change in Visoelastic parameters, in particular the % change in the alpha angle will be calculated for each study participant and the effect size of the differences in the change, and 95% confidence interval.
Measured: pre intervention through 24 hours post intervention
Costs of blood products [Time Frame: 24 hours]
The costs (USD) of blood products used per intervention group will be collected 24 hours post-surgery and reported as the mean (USD).
Measured: 24 hours post-surgery
Costs of IV hemostatic agents [Time Frame: 24 hours]
The costs (USD) of IV hemostatic agents used per intervention group will be collected 24 hours post-surgery and reported as the mean (USD).
Measured: 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start21 May 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant SurgeryStudies 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
- Model description
- Prospective, multi-center, unblinded, randomized controlled study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trauma Hemostatis and Oxygenation Research (THOR) Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265843
- Sponsor's protocol ID
- FITS
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrinogen in Liver Transplant Subjects (FITS)
- ClinicalTrials.gov ID
- NCT07265843
- Acronym / sponsor ID
- FITS
- Conditions
- Liver Transplant Surgery
- Keywords
- Cryoprecipitate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Trauma Hemostatis and Oxygenation Research (THOR) NetworkUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 5 Dec 2025 (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.
The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of two approved products Intercept Fibrinogen Complex (IFC) to Standard Cryoprecipitate Antihemophilic Factor (AHF) for liver transplant patients with bleeding and hypofibrinogenemia to determine impact of earlier access to a concentrated source of fibrinogen in a goal-directed manner.
Detailed description
Fibrinogen is an important factor for hemostasis and when it is deficient or dysfunctional replacing it will improve hemostasis and reduce bleeding. Observational data indicates the use of cryoprecipitate as a source of fibrinogen may reduce bleeding and improve outcomes in patients with severe bleeding. Liver transplant patients often become hypofibrinogenemic and may benefit from early goal directed use of cryoprecipitate or IFC. IFC can be more readily available since it can be stored at room temperature compared to cryoprecipitate which requires thawing. As a result, IFC can be immediately available when indicated compared to the delay in administration of cryoprecipitate due to the need for it to be thawed. This trial will compare clinical outcomes for subjects randomized to either cryoprecipitate or IFC in bleeding liver transplant patients with reduced fibrinogen function.
There is no data comparing outcomes for subjects receiving IFC or cryoprecipitate in any patient population.
The rationale for this trial is to compare IFC to cryoprecipitate (cryo) to assist with the design of a future definitive multicenter trial. Potential advantages of IFC are that since it is stored at room temperature it can be made immediately available whereas with cryo the delay in treatment can be 30 to 40 min due to the need to thaw it from a frozen state. The reduced time to treatment of bleeding may improve outcomes with the use of IFC compared to cryo. In vitro data indicates similar hemostatic function between IFC and Cryo. IFC is pathogen reduced cryoprecipitate. The pathogen reduction methods are licensed for IFC and there has been no safety concerns regarding its use at the centers that are currently using it as their standard product (unpublished).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multi-center, unblinded, randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Standard Antihemophilic Factor (AHF) | Active comparator | Biological: Cryoprecipitate Antihemophilic Factor (AHF)AHF is the standard of care fibrinogen product often used in liver transplant cases. The procedures to use AHF include requesting the order of this product and then waiting for the product to be thawed for use, which can take approximately 10-15 minutes. Subjects assigned to this group will receive all standard of care procedures, including the use of AHF if required during their scheduled surgery. |
| Intercept Fibrinogen Complex (IFC) | Active comparator | Biological: Intercept Fibrinogen Complex (IFC)IFC is an approved fibrinogen product that is not typically stored in the OR for liver transplant cases. Subjects assigned to this group will receive standard of care procedures, with the addition of IFC being readily available in their designated OR to eliminate any delay if they are to require the use of a fibrinogen product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Scheduled to undergo cadaveric liver transplant
- Meets at least one of the following criteria: Baseline fibrinogen <200 mg/dL or clinically significant visoelastic testing
- Meets any one of the following criteria: Alcoholic cirrhosis, Metabolic dysfunction associated steatohepatitis (MASH) (previously known as Nonalcoholic Steatohepatitis (NASH)), HCV infection
Key exclusion criteria (8 listed)
- Living related donor transplant,
- Known prothrombotic disorder,
- Patient objection to blood transfusion,
- Known severe allergic reaction to plasma-based products,
- IgA deficiency with known hypersensitivity reaction to plasma,
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 |
|---|---|---|
| Intercept Fibrinogen Complex (IFC)INTERCEPT Fibrinogen Complex is a pathogen-reduced cryoprecipitated fibrinogen complex derived from human plasma. It contains fibrinogen, Factor XIII, and von Willebrand factor to achieve stable clot formation and restore hemostasis. Recently approved by the US Food and Drug Administration, it is used for the treatment of bleeding associated with fibrinogen deficiency. | Biological | Intercept Fibrinogen Complex (IFC) |
| Cryoprecipitate Antihemophilic Factor (AHF)Cryoprecipitate Antihemophilic Factor (AHF), also known as cryo, is a frozen blood product prepared from blood plasma. It is used for fibrinogen supplementation, particularly for hypofibrinogenemia fibrinogen, anemia associated with bleeding or congenital deficiency. | Biological | Standard Antihemophilic Factor (AHF) |
Primary outcome
Amount of blood products (24-hours) [Time Frame: 24-hours after initial blood product administration]
Time frame: 24-hour
The amount of blood products (mL) administered will be collected at the 24-hour timepoint per intervention group and reported as the mean (mL).
3 secondary outcomes
Change in Visoelastic parameters [Time Frame: pre-intervention through 24 hours post intervention]
Time frame: pre intervention through 24 hours post intervention
Costs of blood products [Time Frame: 24 hours]
Time frame: 24 hours post-surgery
Costs of IV hemostatic agents [Time Frame: 24 hours]
Time frame: 24 hours post-surgery
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 19 Oct 2026.
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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 Intercept Fibrinogen Complex (IFC) and Cryoprecipitate Antihemophilic Factor (AHF) in people with Liver Transplant Surgery, run by Trauma Hemostatis and Oxygenation Research (THOR) Network at 1 site in United States.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. 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 United States. 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 Meghan Huff Research Nurse, BSN (6185789309, mhuff@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of blood products (24-hours) [Time Frame: 24-hours after initial blood product administration] (time frame: 24-hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.