The Efficacy of the Administration of Fibrinogen in Liver Transplantation
NCT ID: NCT01539057
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
132 participants
INTERVENTIONAL
2012-07-31
2015-01-31
Brief Summary
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* 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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intravenous Fibrinogen
Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved.
Fibrinogen
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
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
Saline
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
Interventions
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Fibrinogen
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
Saline
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / L.
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Spanish Clinical Research Network - SCReN
NETWORK
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Antoni Sabate
Head of Anesthesiology
Principal Investigators
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Antoni Sabate, MD
Role: STUDY_DIRECTOR
Hospital Universitari Bellvitge.IDIBELL
Locations
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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
Countries
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References
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Perez L, Sabate A, Gutierrez R, Caballero M, Pujol R, Llaurado S, Penafiel J, Hereu P, Blasi A. Risk factors associated with blood transfusion in liver transplantation. Sci Rep. 2024 Aug 16;14(1):19022. doi: 10.1038/s41598-024-70078-2.
Caballero M, Sabate A, Perez L, Vidal J, Reverter E, Gutierrez R, Crespo G, Penafiel J, Blasi A. Factors associated with mechanical ventilation longer than 24 h after liver transplantation in patients at risk for bleeding. BMC Anesthesiol. 2023 Nov 2;23(1):356. doi: 10.1186/s12871-023-02321-8.
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.
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.
Other Identifiers
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2010-024584-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Promotor Code 1553-H-459
Identifier Type: -
Identifier Source: org_study_id