NCT02763410: TRANSNEPHRON

Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation

Completed Last updated 1 April 2024

What this trial tests

trial testing PRBC transfusion in Renal Failure in 199 participants. Completed in 23 March 2022.

Timeline

8 September 2016

Primary endpoint
23 March 2022

23 March 2022

Quick facts

Lead sponsor	Nantes University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	199
Start date	8 September 2016
Primary completion	23 March 2022
Estimated completion	23 March 2022
Sites	1 location across France

Drugs / interventions tested

• PRBC transfusion

Conditions studied

• Renal Failure — all drugs for Renal Failure →

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Renal Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trauma-Induced Damage-Associated Molecular Patterns-Mediated Remote Organ Injury and Immunosuppression in the Acutely Ill Patient.
   Vourc'h M, Roquilly A, Asehnoune K. · · 2018 · cited 105× · PMID 29963048 · DOI 10.3389/fimmu.2018.01330
2. Transfusion-Related Renal Dysfunction After Cardiac Surgery: The Role of Myeloid-Related Protein_14 in Neutrophil-Mediated Tubular Damage.
   Vourc'h M, Roquilly A, Foucher A, Retiere C, et al · · 2022 · cited 8× · PMID 35958696 · DOI 10.1016/j.jacbts.2022.02.019