NCT01539057

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

February 2, 2012

Last Update Submit

December 3, 2014

Conditions

Intraoperative Bleeding

Keywords

LiverSurgeryhemostasiscoagulationFibrinogen

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients requiring transfusion of packed red blood cells during the procedure

    record of number of red blood cell packeds transfused during the surgical procedure

    intraoperative

Secondary Outcomes (3)

  • Percentage of patients requiring blood products other than red cell concentrates

    intraoperative

  • Operative outcome

    4 weeks

  • liver transplantation outcome

    1 year

Study Arms (2)

Intravenous Fibrinogen

EXPERIMENTAL

Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved.

Drug: Fibrinogen

Saline Serum

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

FibrinogenDRUG

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

Also known as: Haemocomplettan, RiaSTAP
Intravenous Fibrinogen
SalineDRUG

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

Also known as: physiologic serum
Saline Serum

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients candidates for liver transplantation
  • Patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / L.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitari de Bellvitge

Barcelona, Barcelona, 08907, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Murcia, Spain

Location

Hospital Virgen del Rocio

Seville, Sevilla, Spain

Location

Hospital de Cruces

Bilbao, Vizcaya, Spain

Location

Related Publications (4)

  • 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.

    PMID: 39152310DERIVED

  • 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.

    PMID: 37919695DERIVED

  • 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.

    PMID: 28990201DERIVED

  • 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.

    PMID: 26880105DERIVED

MeSH Terms

Conditions

Blood Loss, SurgicalThrombosis

Interventions

FibrinogenSodium Chloride

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Antoni Sabate, MD

    Hospital Universitari Bellvitge.IDIBELL

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 27, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2013

Study Completion

January 1, 2015

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

ES(4)