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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180869
First Posted: September 16, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180869


Locations
France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Valerie Lapierre, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

ClinicalTrials.gov Identifier: NCT00180869     History of Changes
Other Study ID Numbers: TRANSFUGE
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
cancer
peroperative transfusion
allogeneic red blood cell concentrate
leuko-reduced red blood cell concentrate