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
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
Treatments tested in this trial
- Intercept Fibrinogen Complex (IFC)
- Cryoprecipitate Antihemophilic Factor (AHF)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov