The Efficacy of the Administration of Fibrinogen in Liver Transplantation
- Registration Number
- NCT01539057
- Lead Sponsor
- Hospital Universitari de Bellvitge
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 132
- Patients candidates for liver transplantation
- Patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / L.
- Patients with a value of fibrinogen in the 24 hours prior to the intervention than 2.9 g / L.
- Known history of thromboembolic events in 30 days
- Known or suspected pregnancy
- Previous randomization in this trial
- Known or suspected allergy to trial products or related products
- Known presence of congenital bleeding disorder. Patients treated with aspirin, warfarin
- The following indications for transplantation: familial polyneuropathy, acute liver failure, biliary cirrhosis and sclerosing cholangitis, Budd-Chiari syndrome
- Heart beating donors and living donor
- Patient reluctant to participate in the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Serum Saline the same dose in volume of saline 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 saline dilution Intravenous Fibrinogen Fibrinogen Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved.
- Primary Outcome Measures
Name Time Method Percentage of patients requiring transfusion of packed red blood cells during the procedure intraoperative record of number of red blood cell packeds transfused during the surgical procedure
- Secondary Outcome Measures
Name Time Method Percentage of patients requiring blood products other than red cell concentrates intraoperative * 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 surgeryOperative outcome 4 weeks * Operative mortality
* Liver graft survival
* Thrombotic complications of all types and causesliver transplantation outcome 1 year Follow-up of graft survival and patient mortality one year after liver transplantation.
Trial Locations
- Locations (4)
Hospital Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital de Cruces
🇪🇸Bilbao, Vizcaya, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain