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Fibrinogen in Liver Transplant Subjects

NCT06764927 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2026-05-07

No results posted yet for this study

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 bleeding and hypofibrinogenemia to determine impact of earlier access to a concentrated source of fibrinogen in a goal-directed manner.

Conditions

  • Liver Transplant Surgery

Interventions

BIOLOGICAL

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

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.

Sponsors & Collaborators

  • Ezeldeen Abuelkasem

    lead OTHER

Principal Investigators

  • Ezeldeen Abuelkasem, MBBCh, MSc · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-03-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06764927 on ClinicalTrials.gov