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| Name | Class |
|---|---|
| Etablissement Français du Sang | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRBC transfusion | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| link between the composition of the PRBC supernatant and the onset of renal failure | 48 hours following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory dysfunction in the ICU defined by a blood pressure of oxygen (PaO2)/inspired oxygen fraction (FiO2) ratio < 300 on at least one occasion | within 28 days | |
| Number of dialysis days | within 28 days |
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Inclusion Criteria:
And no indication of pre-surgical PRBC transfusion (priming excluded), And no indication of transfusion with fresh frozen plasma or pre-surgical platelet concentrate
Exclusion Criteria:
Exclusion criteria analysis
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Patients:
The investigators selected cardiac surgery patients for the transfusion frequency and significant post-surgical renal morbidity.
Study centre:
The study will take place at the CHU Nantes (University Hospital Centre) where over 1500 extracorporeal circulation procedures are performed annually.
Number of patients required: 200 patients:
100 transfusion patients who have developed renal failure; 100 transfusion patients who have not developed renal failure;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | 44093 | France |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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urine samples and PRBC tubing
| Duration of stay | within 28 days |
| Ventilation period (in hours); | within 28 days |
| ICU-acquired infection | within 28 days |
| Status at discharge from ICU: Dead/alive | day 28 |
| Study of transfusion-related accidents recorded in ICU | within 28 days |
| Hospital admission, regardless of cause | 1 year |
| Hospital admission due to infection | 1 year |
| Diagnosis of cancer | 1 year |
| Clinical course of pre-existing cancer | 1 year |
| Survival | 1 year |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |