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Completed

NCT Number: NCT00235183

Plasma Transfusion in Liver Transplantation

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.

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Key information

Conditions

Bleeding in Liver Transplantation Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

EFS

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plasma

Other

transfusion of more than 15 mL/Kg of plasma

Primary outcomes

  1. Volume of transfused plasma during surgery

    Time frame: 5 years

Secondary outcomes

  1. correction of coagulation abnormalities

    Time frame: 5 years

  2. immediate and delayed adverse events

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Etablissement Français du Sang

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Oct 10, 2005
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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