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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
132
The dose of fibrinogen should be calculated at 1 g of fibrinogen in order to obtain an increase in plasma fibrinogen value of 0.29 g / L to reach a final value of 2.9 g / L. Fibrinogen ampoules powder prepared with water dilution and located in a serum at a concentration of 2g/100 ml, which will be administered by intravenous infusion for 10 minutes. Administration before surgery starts
the same dose in volume of water dilution will be administered. The potential dose of fibrinogen required to obtain a final plasmatic reading of 2.9 g / L. will be computed. A serum will contain the corresponding ml of water dilution. Administered before surgery starts
Hospital Universitari de Bellvitge
Barcelona, Barcelona, Spain
Hospital Virgen de la Arrixaca
Murcia, Murcia, Spain
Hospital Virgen del Rocio
Seville, Sevilla, Spain
Hospital de Cruces
Bilbao, Vizcaya, Spain
Percentage of patients requiring transfusion of packed red blood cells during the procedure
record of number of red blood cell packeds transfused during the surgical procedure
Time frame: intraoperative
Percentage of patients requiring blood products other than red cell concentrates
* Number of packed red cells transfused during surgery * Number of units of fresh frozen plasma transfused during surgery * Number of platelet units transfused during surgery * Grams of fibrinogen administered during surgery
Time frame: intraoperative
Operative outcome
* Operative mortality * Liver graft survival * Thrombotic complications of all types and causes
Time frame: 4 weeks
liver transplantation outcome
Follow-up of graft survival and patient mortality one year after liver transplantation.
Time frame: 1 year
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