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Trial · Interventional

CompletedPhase 4Registry data

Plasma Transfusion in Liver Transplantation

NCTNCT00235183 (opens ClinicalTrials.gov in a new tab)Other idEFS plasma trial
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Overview

Status
Completed
Phase
Phase 4
Enrollment
300 participants (estimated)
Sponsor
Etablissement Français du Sang · Other
Design
Randomized · Quadruple masking
Countries
1 country

France

Start
Jun 2005
Primary completion
Dec 2009
Completion
Dec 2010
First posted
10 Oct 2005 (estimated)
Last update posted
17 Feb 2014 (estimated)
Conditions
Bleeding in Liver Transplantation

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2005200620072008200920102011
  1. Ph 4

    Plasma Transfusion in Liver Transplantation

    NCT00235183

    Jun 2005 to Dec 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • plasmaOther

Arms3

  • Active comparator

    Quarantined FFP

    Quarantined FFP

  • Active comparator

    Methylene blue FFP

    Methylene blue FFP

  • Active comparator

    Solvent detergent FFP

    Solvent detergent FFP

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Volume of transfused plasma during surgery

    Time frame · 5 years

Secondary outcomes(2)

  1. correction of coagulation abnormalities

    Time frame · 5 years

  2. immediate and delayed adverse events

    Time frame · 15 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedBartelmaos 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. PMID 22998014

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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