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A Randomized Study of Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients


Phase 3
18 Years
70 Years
Not Enrolling
Both
Cancer, Surgery

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Trial Information

A Randomized Study of Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Valerie Lapierre, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Ministry of Health

Study ID:

TRANSFUGE

NCT ID:

NCT00180869

Start Date:

September 1997

Completion Date:

Related Keywords:

  • Cancer
  • Surgery
  • cancer
  • peroperative transfusion
  • allogeneic red blood cell concentrate
  • leuko-reduced red blood cell concentrate

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