Liver Transplant SurgeryPhase 4FITSNCT06764927
Fibrinogen in Liver Transplant Subjects
A Phase 4 study testing Cryoprecipitate Intercept Fibrinogen Complex (IFC) and Cryoprecipitate Antihemophilic Factor (AHF) in people with Liver Transplant Surgery, run by Ezeldeen Abuelkasem at 3 sites 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 Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC) to Standard Cryoprecipitate Antihemophilic Factor (AHF) for liver transplant patients with… 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?
- Cryoprecipitate Intercept Fibrinogen Complex (IFC) and Cryoprecipitate Antihemophilic Factor (AHF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jan 2026to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Alcoholic cirrhosis
- Nonalcoholic Steatohepatitis (NASH)
- HCV infection
Who cannot join
- Living related donor transplant
- DCD liver recipient
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Cincinnati
Cincinnati, Ohio, 45221
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
About this study
The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of Investigational Cryoprecipitate 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 definitice multicenter trial. Potential advantages of IFC are that since it is stored at room temperature it can be made immediatwlt 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
- Cryoprecipitate Intercept Fibrinogen Complex (IFC), Cryoprecipitate Antihemophilic Factor (AHF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoprecipitate 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 hemostasis1. 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 Cryoprecipitate Antihemophilic Factor (AHF) | Active comparator | AHF is the standard of care plasma product often used in liver transplant cases. The procedures to implementing AHF include requesting the order of this plasma 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) |
| Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC) | Active comparator | IFC is an approved plasma 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 plasma product. Receives: Biological: Cryoprecipitate 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)
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-hours after initial blood product administration
Secondary outcomes (3)
Change in TEG parameters
Change in TEG 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: 14 days post-surgery
Costs of blood products
The costs (USD) of blood products used per intervention group will be collected 14-days post-surgery and reported as the mean (USD).
Measured: 14 days post-surgery
Costs of IV hemostatic agents
The costs (USD) of IV hemostatic agents used per intervention group will be collected 14-days post-surgery and reported as the mean (USD).
Measured: 14 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start31 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Why it stopped: No supply of the test substance was provided by the sponsor.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ezeldeen Abuelkasem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ezeldeen Abuelkasem, University of Pittsburgh
- Investigators
- Ezeldeen Abuelkasem, MBBCh, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764927
- Sponsor's protocol ID
- STUDY24070113
- Acronym
- FITS
- Status last verified
- Aug 2025
- First submitted
- 18 Dec 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the participating site, University of Cincinnati College of Medicine, will be shared with Pitt. In the future, the investigators may decide to share data with other investigators both within and outside of the institution. If this were to occur, we would de-identify all of the information prior to sharing data in this way. The Office of Sponsored Programs will be contacted prior to sharing data to determine if a date use agreement is necessary.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrinogen in Liver Transplant Subjects
- ClinicalTrials.gov ID
- NCT06764927
- Acronym / sponsor ID
- FITS / STUDY24070113
- Conditions
- Liver Transplant Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No supply of the test substance was provided by the sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ezeldeen AbuelkasemUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 9 Jan 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 Investigational Cryoprecipitate 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 definitice multicenter trial. Potential advantages of IFC are that since it is stored at room temperature it can be made immediatwlt 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 Cryoprecipitate Antihemophilic Factor (AHF) | Active comparator | Biological: Cryoprecipitate Antihemophilic Factor (AHF)AHF is the standard of care plasma product often used in liver transplant cases. The procedures to implementing AHF include requesting the order of this plasma 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. |
| Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC) | Active comparator | Biological: Cryoprecipitate Intercept Fibrinogen Complex (IFC)IFC is an approved plasma 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 plasma product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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
- Alcoholic cirrhosis
Key exclusion criteria (8 listed)
- Living related donor transplant
- DCD liver recipient
- Known prothrombotic disorder
- Patient objection to blood transfusion
- Known severe allergic reaction to plasma-based products
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 |
|---|---|---|
| Cryoprecipitate 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 hemostasis1. Recently approved by the US Food and Drug Administration, it is used for the treatment of bleeding associated with fibrinogen deficiency. | Biological | Investigational Cryoprecipitate 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 Cryoprecipitate Antihemophilic Factor (AHF) |
Primary outcome
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).
3 secondary outcomes
Change in TEG parameters
Time frame: 14 days post-surgery
Costs of blood products
Time frame: 14 days post-surgery
Costs of IV hemostatic agents
Time frame: 14 days post-surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. Data from the participating site, University of Cincinnati College of Medicine, will be shared with Pitt. In the future, the investigators may decide to share data with other investigators both within and outside of the institution. If this were to occur, we would de-identify all of the information prior to sharing data in this way. The Office of Sponsored Programs will be contacted prior to sharing data to determine if a date use agreement is necessary.
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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. This study is not recruiting at the moment.
Ezeldeen Abuelkasem, MBBCh, MSc principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cryoprecipitate Intercept Fibrinogen Complex (IFC) and Cryoprecipitate Antihemophilic Factor (AHF) in people with Liver Transplant Surgery, run by Ezeldeen Abuelkasem at 3 sites 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 7 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: withdrawn, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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). 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 7 May 2026.