Clinical trial · Interventional
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
NCT00180869CI-TRIAL-00122837completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| transfusion of allogeneic red blood cell concentrate | Procedure | — | UNRESOLVED |
| transfusion of leuko-reduced red blood cell concentrate | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio
Secondary outcomes (6)
- measure
- Peripheral blood mononuclear cell phenotyping
- measure
- Cytokine production
- measure
- Microchimerism at day 3 after transfusion during surgery
- measure
- Alteration of T cell repertoire
- measure
- Incidence of nosocomial infection
- measure
- Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTLapierre V, Auperin A, Robinet E, Ferrand C, Oubouzar N, Tramalloni D, Saas P, Debaene B, Lasser P, Tiberghien P. Immune modulation and microchimerism after unmodified versus leukoreduced allogeneic red blood cell transfusion in cancer patients: results of a randomized study. Transfusion. 2007 Sep;47(9):1691-9. doi: 10.1111/j.1537-2995.2007.01344.x. PMID 17725736