The Efficacy of the Administration of Fibrinogen in Liver Transplantation (FibstudLT)
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation|
- Percentage of patients requiring transfusion of packed red blood cells during the procedure [ Time Frame: intraoperative ] [ Designated as safety issue: No ]record of number of red blood cell packeds transfused during the surgical procedure
- Percentage of patients requiring blood products other than red cell concentrates [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
- 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
- Operative outcome [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Operative mortality
- Liver graft survival
- Thrombotic complications of all types and causes
- liver transplantation outcome [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Follow-up of graft survival and patient mortality one year after liver transplantation.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Intravenous Fibrinogen
Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved.
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
Placebo Comparator: Saline Serum
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
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
Other Name: physiologic serum
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539057
|Contact: Antoni Sabate, MDemail@example.com|
|Hospital de Cruces||Recruiting|
|Bilbao, Vizcaya, Spain|
|Principal Investigator: Rosa Gutierrez, MD|
|Barcelona, Spain, 08 005|
|Principal Investigator: Joan Beltran, MD|
|Hospital Universitari de Bellvitge||Recruiting|
|Barcelona, Spain, 08907|
|Contact: Antoni Sabate, PhD MD firstname.lastname@example.org|
|Principal Investigator: Antoni Sabate, MD|
|Hospital Virgen de la Arrixaca||Recruiting|
|Principal Investigator: Francisco Acosta, MD|
|Hospital Virgen del Rocio||Recruiting|
|Principal Investigator: Juan Luis Lopez-Romero, MD|
|Study Director:||Antoni Sabate, MD||Hospital Universitari Bellvitge.IDIBELL|