Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180869
Status:
COMPLETED
Last Update Posted:
2005-09-16
First Post:
2005-09-12
Brief Title:
Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion in Cancer Patients
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
A Randomized Study of Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 transfusionsurgery 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 IL4IFNgamma 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None