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The Efficacy of the Administration of Fibrinogen in Liver Transplantation (FibstudLT)

Primary Purpose

Intraoperative Bleeding

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Fibrinogen
Saline
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Bleeding focused on measuring Liver, Surgery, hemostasis, coagulation, Fibrinogen

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Cruces
  • Hospital Universitari de Bellvitge
  • Hospital Virgen de la Arrixaca
  • Hospital Virgen del Rocio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravenous Fibrinogen

Saline Serum

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of patients requiring blood products other than red cell concentrates
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
Operative mortality Liver graft survival Thrombotic complications of all types and causes
liver transplantation outcome
Follow-up of graft survival and patient mortality one year after liver transplantation.

Full Information

First Posted
February 2, 2012
Last Updated
December 3, 2014
Sponsor
Hospital Universitari de Bellvitge
Collaborators
Spanish Clinical Research Network - SCReN
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1. Study Identification

Unique Protocol Identification Number
NCT01539057
Brief Title
The Efficacy of the Administration of Fibrinogen in Liver Transplantation
Acronym
FibstudLT
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
Collaborators
Spanish Clinical Research Network - SCReN

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Bleeding
Keywords
Liver, Surgery, hemostasis, coagulation, Fibrinogen

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Fibrinogen
Arm Type
Experimental
Arm Description
Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved.
Arm Title
Saline Serum
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fibrinogen
Other Intervention Name(s)
Haemocomplettan, RiaSTAP
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
physiologic serum
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of patients requiring transfusion of packed red blood cells during the procedure
Description
record of number of red blood cell packeds transfused during the surgical procedure
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Percentage of patients requiring blood products other than red cell concentrates
Description
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
Time Frame
intraoperative
Title
Operative outcome
Description
Operative mortality Liver graft survival Thrombotic complications of all types and causes
Time Frame
4 weeks
Title
liver transplantation outcome
Description
Follow-up of graft survival and patient mortality one year after liver transplantation.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Sabate, MD
Organizational Affiliation
Hospital Universitari Bellvitge.IDIBELL
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Cruces
City
Bilbao
State/Province
Vizcaya
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28990201
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.
Results Reference
derived
PubMed Identifier
26880105
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.
Results Reference
derived

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The Efficacy of the Administration of Fibrinogen in Liver Transplantation

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