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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cancer Surgery

Keywords

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cancer peroperative transfusion allogeneic red blood cell concentrate leuko-reduced red blood cell concentrate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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transfusion of allogeneic red blood cell concentrate

Intervention Type PROCEDURE

transfusion of leuko-reduced red blood cell concentrate

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Valerie Lapierre, PhD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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TRANSFUGE

Identifier Type: -

Identifier Source: org_study_id