NCT00180869

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 16, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

CancerSurgery

Keywords

cancerperoperative transfusionallogeneic red blood cell concentrateleuko-reduced red blood cell concentrate

Outcome Measures

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 (6)

  • Peripheral blood mononuclear cell phenotyping

  • Cytokine production

  • Microchimerism at day 3 after transfusion during surgery

  • Alteration of T cell repertoire

  • Incidence of nosocomial infection

  • +1 more secondary outcomes

Interventions

transfusion of allogeneic red blood cell concentratePROCEDURE
transfusion of leuko-reduced red blood cell concentratePROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgery for cancer with a transfusion during surgery risk greater than 30%
  • Surgery in curative intent
  • Written informed consent

You may not qualify if:

  • contraindications to the use of allogeneic unmodified red blood cell concentrate
  • any anti-RBC and/or anti-HLA and/or anti-granulocyte alloimmunization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Valerie Lapierre, PhD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

September 1, 1997

Last Updated

September 16, 2005

Record last verified: 2005-09

Locations

FR(1)