Clinical trial NCT01539057: The Efficacy of the Administration of Fibrinogen in Liver Transplantation
Official title: A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Intraoperative Bleeding
Keywords: Liver
Surgery
hemostasis
coagulation
Fibrinogen
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
First posted: 2012-02-27
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients requiring transfusion of packed red blood cells during the procedure
timeFrame: intraoperative
Secondary outcomes:
measure: Percentage of patients requiring blood products other than red cell concentrates
timeFrame: intraoperative
measure: Operative outcome
timeFrame: 4 weeks
measure: liver transplantation outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
Study officials:
affiliation: Hospital Universitari Bellvitge.IDIBELL
name: Antoni Sabate, MD
role: STUDY_DIRECTOR
References:
citation: Blasi A, Sabate A, Beltran J, Costa M, Reyes R, Torres F. Correlation between plasma fibrinogen and FIBTEM thromboelastometry during liver transplantation: a comprehensive assessment. Vox Sang. 2017 Nov;112(8):788-795. doi: 10.1111/vox.12598. Epub 2017 Oct 8.
citation: Sabate A, Gutierrez R, Beltran J, Mellado P, Blasi A, Acosta F, Costa M, Reyes R, Torres F. Impact of Preemptive Fibrinogen Concentrate on Transfusion Requirements in Liver Transplantation: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Transplant. 2016 Aug;16(8):2421-9. doi: 10.1111/ajt.13752. Epub 2016 Mar 17.