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

This study has been completed.
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00180869
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study of Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00180869     History of Changes
Other Study ID Numbers: TRANSFUGE
Study First Received: September 12, 2005
Last Updated: September 12, 2005
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 May 16, 2013