Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation (TRANSNEPHRON)
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|ClinicalTrials.gov Identifier: NCT02763410|
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : September 20, 2019
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 3.5% 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
|Condition or disease||Intervention/treatment|
|Renal Failure||Other: PRBC transfusion|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Impact of the Composition of the Packed Red Blood Cell Supernatant on Renal Dysfunction and Post-transfusion Immunomodulation|
|Actual Study Start Date :||September 8, 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Patients who received between 1 and 5 PRBCs between incision and the 6th hour post-surgery, with no renal failure at the 48th hour after surgery, based on the RIFLE classification, and regardless of the transfusion received after the H6 assessment.
Other: PRBC transfusion
Renal failure group
Patients who received between 1 and 5 PRBCs between incision and the 6th hour post-surgery and who developed renal failure before H48 with no new transfusion prior to diagnosis of kidney failure.
Other: PRBC transfusion
- link between the composition of the PRBC supernatant and the onset of renal failure [ Time Frame: 48 hours following surgery ]
- Respiratory dysfunction in the ICU defined by a blood pressure of oxygen (PaO2)/inspired oxygen fraction (FiO2) ratio < 300 on at least one occasion [ Time Frame: within 28 days ]
- Number of dialysis days [ Time Frame: within 28 days ]
- Duration of stay [ Time Frame: within 28 days ]
- Ventilation period (in hours); [ Time Frame: within 28 days ]
- ICU-acquired infection [ Time Frame: within 28 days ]
- Status at discharge from ICU: Dead/alive [ Time Frame: day 28 ]
- Study of transfusion-related accidents recorded in ICU [ Time Frame: within 28 days ]
- Hospital admission, regardless of cause [ Time Frame: 1 year ]
- Hospital admission due to infection [ Time Frame: 1 year ]
- Diagnosis of cancer [ Time Frame: 1 year ]
- Clinical course of pre-existing cancer [ Time Frame: 1 year ]
- Survival [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763410
|Contact: Roquilly Antoine, PH||02 40 08 30 firstname.lastname@example.org|
|Contact: Vourch Mickael, PH||02 40 08 30 email@example.com|
|CHU de Nantes||Recruiting|
|Nantes, France, 44093|
|Contact: Roquilly Antoine, PH 02 40 08 30 08 firstname.lastname@example.org|
|Contact: Vourc'h Mickael, PH 02 40 08 30 08 email@example.com|