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NCT Number: NCT00180869

Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion 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.

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Key information

Conditions

Cancer Neoplasms Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Gustave Roussy

Villejuif, 94800, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transfusion of allogeneic red blood cell concentrate

Procedure

transfusion of leuko-reduced red blood cell concentrate

Procedure

Primary outcomes

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

Secondary outcomes

  1. Peripheral blood mononuclear cell phenotyping

  2. Cytokine production

  3. Microchimerism at day 3 after transfusion during surgery

  4. Alteration of T cell repertoire

  5. Incidence of nosocomial infection

  6. Survival

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

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

Important dates

Study start
1997
First posted
Sep 16, 2005
Registry last updated
Sep 16, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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