Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery

Konkuk University Medical Center

Status and phase: Not yet enrolling; Phase 4

Conditions: Liver Diseases

Treatments: Biological: fresh frozen plasma; Biological: prothrombin complex concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT06144112

HC22195220002003

Details and patient eligibility

About

We compared the time consumed for goal-directed management of hypofibrinogemia using two strategies during liver transplant (LT) surgery: a conventional cryoprecipitate-based strategy versus a lyophilized fibrinogen concentrate-based strategy

Full description

The primary outcome is an inter-group comparison of treatment time (T-time, the duration from ordering cryoprecipitate or FC to completing its administration). The secondary measures include comparisons of perioperative bleeding, blood transfusion, coagulation profiles, reoperation, thromboembolic complications, mortality, oxygenation profiles, fibrinolysis phenotypes, and costs for bleeding management and length of hospital stay.

Enrollment: 92 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Liver disease undergoing Liver transplantation

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

cryoprecipitate

Active Comparator group

Description:

If serum-fibrinogen \< 100 mg/dl or CFF-MA \< 15 mm in thromboelastography (TEG), cryoprecipitate is administered

Treatment:

Biological: fresh frozen plasma

fibirnogen concentrate

Experimental group

Description:

If serum-fibrinogen \< 80 mg/dl or CFF-MA \< 15 mm in thromboelastography (TEG), fibrinogen concentrate is administered.

Treatment:

Biological: prothrombin complex concentrate