Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02763410
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2016-04-29
Brief Title:
Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Impact of the Composition of the Packed Red Blood Cell Supernatant on Renal Dysfunction and Post-transfusion Immunomodulation
Status:
COMPLETED
Status Verified Date:
2024-03
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:
TRANSNEPHRON
Brief Summary:
Safety during transfusions is a major issue in medical economics Despite drastic quality control measures transfusion is still a source of short mid and long-term morbi-mortality This can be explained to some extent by changes in the composition of the packed red blood cell PRBC supernatant during storage essentially with the appearance of immunologically active compounds possibly involved in organ dysfunction on the one hand and post-transfusion immunomodulation on the other hand These phenomena impact upon outcomes for cardiac surgery patients
In terms of organ dysfunction kidney failure due to acute tubular necrosis and pulmonary failure are the 2 main issues Following cardiac surgery 11 of patients will present with transient renal dysfunction characterised by a 25 increase in serum creatinine levels and 35 require dialysis The intensity of acute renal failure ARF is correlated to resuscitation a 20 increase in serum creatinine levels 2 to 3 days after surgery significantly raises morbidity rates and a 50 increase raises the mortality rate to 10
The precise mechanisms governing post-transfusion immunomodulation have not yet to be defined The appearance of soluble type I Human leukocytes Antigen HLA molecules sHLA-I the FAS ligand FAS-L or cluster designation 40 CD40-L in the supernatant of PRBCs along the storage of blood products may be involved in such phenomena These molecules are capable of activating or triggering the death of innate or adaptive immunity cells especially the Natural Killer NK cells
Consequently the investigators propose to focus specifically on the detailed composition of transfused PRBC supernatants in order to identify the candidate molecules responsible for organ dysfunction or post-transfusion immunoparalysis The investigators will combine a clinical approach based on the transcriptional analysis of renal tubular cells in transfused patients and an ex-vivo approach investigating the effect of the supernatant on immune cells and the Natural Killer cells of healthy volunteers
In terms of organ dysfunction kidney failure due to acute tubular necrosis and pulmonary failure are the 2 main issues Following cardiac surgery 11 of patients will present with transient renal dysfunction characterised by a 25 increase in serum creatinine levels and 35 require dialysis The intensity of acute renal failure ARF is correlated to resuscitation a 20 increase in serum creatinine levels 2 to 3 days after surgery significantly raises morbidity rates and a 50 increase raises the mortality rate to 10
The precise mechanisms governing post-transfusion immunomodulation have not yet to be defined The appearance of soluble type I Human leukocytes Antigen HLA molecules sHLA-I the FAS ligand FAS-L or cluster designation 40 CD40-L in the supernatant of PRBCs along the storage of blood products may be involved in such phenomena These molecules are capable of activating or triggering the death of innate or adaptive immunity cells especially the Natural Killer NK cells
Consequently the investigators propose to focus specifically on the detailed composition of transfused PRBC supernatants in order to identify the candidate molecules responsible for organ dysfunction or post-transfusion immunoparalysis The investigators will combine a clinical approach based on the transcriptional analysis of renal tubular cells in transfused patients and an ex-vivo approach investigating the effect of the supernatant on immune cells and the Natural Killer cells of healthy volunteers
Detailed Description:
None
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