Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion in Cancer Patients - Full Text View

Sponsored by:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00180869

Purpose

There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have immunomodulatory effects. The aim of this randomized single-center trial is to compare immune responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC) or a leuko-reduced RBC (LR-RBC) transfusion perioperatively.

Condition	Intervention	Phase
Cancer Surgery	Procedure: transfusion of allogeneic red blood cell concentrate Procedure: transfusion of leuko-reduced red blood cell concentrate	Phase III

MedlinePlus related topics: Blood Transfusion and Donation Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	A Randomized Study of Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:

Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio

Secondary Outcome Measures:

Peripheral blood mononuclear cell phenotyping
Cytokine production
Microchimerism at day 3 after transfusion during surgery
Alteration of T cell repertoire
Incidence of nosocomial infection
Survival

Estimated Enrollment:	150
Study Start Date:	September 1997

Detailed Description:

This single-center study is conducted to compare the effect of peroperative transfusion of allogeneic unmodified RBC (UN-RBC) versus leuko-reduced RBC (RED-RBC) on recipient immunity. Patients undergoing cancer surgery are randomly assigned peroperatively to receive UN-RBC or RED-RBC. Groups are stratified for age, sex, tumor characteristics, prior transfusion and prior cancer treatment. Blood sampless are collected before anesthesia (d0) and at days 3, 7, 14 , 28 after transfusion/surgery and analyzed for complete cell blood count, lymphocyte subsets, cytokine production (IL4, IL10, IFNgamma, IL12), T-cells repertoire (TCR) analysis and detection of circulating donor cells. Main study endpoint is the influence of the treatment arm on IL4/IFNgamma ratio. The effect of transfusion type on any given biological parameters is also tested (peripheral blood mononuclear cell phenotyping (PBMC), cytokine production by stimulated PBMC, T cell repertoire analysis and microchimerism assessment).

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Surgery for cancer with a transfusion during surgery risk greater than 30%
Surgery in curative intent
Written informed consent

Exclusion Criteria:

contraindications to the use of allogeneic unmodified red blood cell concentrate
any anti-RBC and/or anti-HLA and/or anti-granulocyte alloimmunization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180869

Locations

France
Institut Gustave Roussy
Villejuif, France, 94800

Sponsors and Collaborators

Institut Gustave Roussy

Investigators

Principal Investigator:

Valerie Lapierre, PhD

Institut Gustave Roussy

More Information

Study ID Numbers:	TRANSFUGE
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00180869
Health Authority:	France: Ministry of Health

Keywords provided by Institut Gustave Roussy:

cancer
peroperative transfusion
allogeneic red blood cell concentrate
leuko-reduced red blood cell concentrate

ClinicalTrials.gov processed this record on January 16, 2009