The Efficacy of the Administration of Fibrinogen in Liver Transplantation
This trial is active, not recruiting.
|Sponsor||Hospital Universitari de Bellvitge|
|Collaborator||Spanish Clinical Research Network - CAIBER|
|Start date||July 2012|
|End date||September 2013|
|Trial size||132 participants|
|Trial identifier||NCT01539057, 2010-024584-41, Promotor Code 1553-H-459|
- 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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Bilbao, Spain||Hospital de Cruces||no longer recruiting|
|Barcelona, Spain||Hospital Universitari de Bellvitge||no longer recruiting|
|Murcia, Spain||Hospital Virgen de la Arrixaca||no longer recruiting|
|Sevilla, Spain||Hospital Virgen del Rocio||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Percentage of patients requiring transfusion of packed red blood cells during the procedure
time frame: intraoperative
Percentage of patients requiring blood products other than red cell concentrates
time frame: intraoperative
time frame: 4 weeks
liver transplantation outcome
time frame: 1 year
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - Patients candidates for liver transplantation - Patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / L. Exclusion Criteria: - 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
|Official title||A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation|
|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.|
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