Plasma Transfusion in Liver Transplantation
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 6, 2005
CompletedFirst Posted
Study publicly available on registry
October 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 17, 2014
February 1, 2014
4.5 years
October 6, 2005
February 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume of transfused plasma during surgery
5 years
Secondary Outcomes (2)
correction of coagulation abnormalities
5 years
immediate and delayed adverse events
15 days
Study Arms (3)
Quarantined FFP
ACTIVE COMPARATORQuarantined FFP
Methylene blue FFP
ACTIVE COMPARATORMethylene blue FFP
Solvent detergent FFP
ACTIVE COMPARATORSolvent detergent FFP
Interventions
transfusion of more than 15 mL/Kg of plasma
Eligibility Criteria
You may qualify if:
- age 18 yo and above
- consent is signed,
- liver transplantation is indicated,
- plasma is transfused
You may not qualify if:
- multiorgan transplantation (except combined kidney and liver transplantation)
- allergy to methylene blue.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
EFS
Paris, 75015, France
Related Publications (1)
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.
PMID: 22998014DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yves Ozier, MD, PhD
Hôpital Cochin, Paris, France
- PRINCIPAL INVESTIGATOR
Emmanuel Samain, MD, PhD
hôpital Jean Minjoz, Besançon, France
- PRINCIPAL INVESTIGATOR
Marie - Christine Gillon, MD
Hôpital Paul Brousse, Villejuif, France
- PRINCIPAL INVESTIGATOR
Loïc Villalon, MD
Hôpital Pontchaillou
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2005
First Posted
October 10, 2005
Study Start
June 1, 2005
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
February 17, 2014
Record last verified: 2014-02