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

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

September 12, 2005
September 12, 2005
September 1997
Not Provided
Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion in Cancer Patients
A Randomized Study of Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Surgery
  • Procedure: transfusion of allogeneic red blood cell concentrate
  • Procedure: transfusion of leuko-reduced red blood cell concentrate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Not Provided
Not Provided

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00180869
TRANSFUGE
Not Provided
Not Provided
Gustave Roussy, Cancer Campus, Grand Paris
Not Provided
Principal Investigator: Valerie Lapierre, PhD Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP