Intraoperative Bleeding Clinical Trial
Official title:
A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation
Objective:
- To evaluate the efficacy of preoperative administration of fibrinogen in liver
transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared
with placebo, reflecting a reduction in the number of RBC units transfused during the
procedure.
- To determine the influence of fibrinogen administration on mortality and survival of
liver graft evaluated one year after the procedure.
- To determine the safety of fibrinogen administration recording thrombotic complications
evaluated during hospitalization or at least 30 days postoperatively.
Methods: A multicenter, randomized, double-blind, placebo-controlled study. One hundred
thirty two patients (132) will randomly be assigned to:
Treatment group, Fibrinogen administration; doses of fibrinogen: 1 g for an increase in the
plasmatic value of fibrinogen of 0.29 g / L to obtain a value of 2.9 g / L.
Placebo group, to whom the same dose volume of saline will be administered.
Determinations of haematocrit, electrolytes and kidney function tests and coagulation and
haemostasis and thrombelastography test are made at all stages of the proceeding. A standard
protocol for intraoperative management will be applied. Blood loss, administration of blood
products, fluid therapy, presence of reperfusion syndrome, operative complications and
mortality and survival will be registered. Patients will be followed for one year after
transplantation.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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