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Plasma Transfusion in Liver Transplantation

Primary Purpose

Bleeding in Liver Transplantation

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

plasma

About this trial

This is an interventional treatment trial for Bleeding in Liver Transplantation focused on measuring plasma, bleeding, liver transplantation

Eligibility Criteria

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

Inclusion Criteria: age 18 yo and above consent is signed, liver transplantation is indicated, plasma is transfused Exclusion Criteria: multiorgan transplantation (except combined kidney and liver transplantation) allergy to methylene blue.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Quarantined FFP

Methylene blue FFP

Solvent detergent FFP

Arm Description

Quarantined FFP

Methylene blue FFP

Solvent detergent FFP

Outcomes

Primary Outcome Measures

Volume of transfused plasma during surgery

Secondary Outcome Measures

correction of coagulation abnormalities

immediate and delayed adverse events

Full Information

NCT ID

NCT00235183

First Posted

October 6, 2005

Last Updated

February 14, 2014

Sponsor

Etablissement Français du Sang

1. Study Identification

Unique Protocol Identification Number

NCT00235183

Brief Title

Plasma Transfusion in Liver Transplantation

Official Title

Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Etablissement Français du Sang

4. Oversight

5. Study Description

Brief Summary

The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.

Detailed Description

Three types of plasma are transfused in bleeding patients undergoing liver transplantation: quarantined plasma, methylene blue treated plasma, solvent/detergent plasma. The main purpose is to show that the volume of methylene blue treated plasma consumed intraoperatively is equivalent to that of the 2 other types of plasma. In addition, the correction of coagulation abnormalities are studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bleeding in Liver Transplantation

Keywords

plasma, bleeding, liver transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Quarantined FFP

Arm Type

Active Comparator

Arm Description

Quarantined FFP

Arm Title

Methylene blue FFP

Arm Type

Active Comparator

Arm Description

Methylene blue FFP

Arm Title

Solvent detergent FFP

Arm Type

Active Comparator

Arm Description

Solvent detergent FFP

Intervention Type

Other

Intervention Name(s)

plasma

Intervention Description

transfusion of more than 15 mL/Kg of plasma

Primary Outcome Measure Information:

Title

Volume of transfused plasma during surgery

Time Frame

5 years

Secondary Outcome Measure Information:

Title

correction of coagulation abnormalities

Time Frame

5 years

Title

immediate and delayed adverse events

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves Ozier, MD, PhD

Organizational Affiliation

Hôpital Cochin, Paris, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Emmanuel Samain, MD, PhD

Organizational Affiliation

hôpital Jean Minjoz, Besançon, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marie - Christine Gillon, MD

Organizational Affiliation

Hôpital Paul Brousse, Villejuif, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Loïc Villalon, MD

Organizational Affiliation

Hôpital Pontchaillou

Official's Role

Principal Investigator

Facility Information:

Facility Name

EFS

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

22998014

Citation

Bartelmaos T, Chabanel A, Leger J, Villalon L, Gillon MC, Rouget C, Gomola A, Denninger MH, Tardivel R, Naegelen C, Courtois F, Bardiaux L, Giraudeau B, Ozier Y. Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas. Transfusion. 2013 Jun;53(6):1335-45. doi: 10.1111/j.1537-2995.2012.03895.x. Epub 2012 Sep 24.

Results Reference

derived

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Plasma Transfusion in Liver Transplantation

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