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Fibrinogen in Liver Transplant

ConditionLiver Transplant Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrauma Hemostatis and Oxygenation Research (THOR) Network

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Scheduled to undergo cadaveric liver transplant

Baseline fibrinogen <200 mg/dL or clinically significant visoelastic testing,

Alcoholic cirrhosis,

Disqualifiers

Living related donor transplant,

Known prothrombotic disorder,

Patient objection to blood transfusion,

Known severe allergic reaction to plasma-based products,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intercept Fibrinogen Complex (IFC)

    Biological/Vaccine

    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/Vaccine

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standard Antihemophilic Factor (AHF)Active comparator 1 intervention
Group B: Intercept Fibrinogen Complex (IFC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
24-hour

Secondary outcomes

1

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.

Time frame
pre intervention through 24 hours post intervention
2

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).

Time frame
24 hours post-surgery
3

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).

Time frame
24 hours post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Trauma Hemostatis and Oxygenation Research (THOR) Network

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: