Clinical trial NCT02841111: Old Red Blood Cell In Renal Transplantation
Official title: Impact of Early Transfusions of Packed Red Cells on the Evolution of Renal Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder Related to Renal Transplantation
Transfusion Reaction
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Agence de La Biomédecine
name: Etablissement Français du Sang
name: Amiens University Hospital
name: University Hospital, Angers
name: Bicetre Hospital
name: University Hospital, Bordeaux
name: University Hospital, Brest
name: University Hospital, Caen
name: University Hospital, Clermont-Ferrand
name: CRC CHI Creteil France
name: Centre Hospitalier Universitaire Dijon
name: Hopital Foch
name: University Hospital, Grenoble
name: Groupe Hospitalier Pitie-Salpetriere
name: University Hospital, Lille
name: University Hospital, Limoges
name: Hôpital Edouard Herriot
name: Centre Hospitalier Lyon Sud
name: University Hospital, Marseille
name: University Hospital, Montpellier
name: Central Hospital, Nancy, France
name: Nantes University Hospital
name: Hôpital Necker-Enfants Malades
name: Centre Hospitalier Universitaire de Nice
name: Poitiers University Hospital
name: CHU de Reims
name: Rennes University Hospital
name: CHU de Rouen - Accueil
name: Centre Hospitalier Universitaire de Saint Etienne
name: Saint-Louis Hospital, Paris, France
name: University Hospital, Strasbourg, France
name: Tenon Hospital, Paris
name: University Hospital, Toulouse
name: University Hospital, Tours
First posted: 2016-07-22
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The impact of early transfusions is determined retrospectively over a period of 6 years from 01 January 2002 to 31 December 2008, in renal transplant patients of all centers of France met the criteria for inclusion. This cohort represents about 12 000-14 000 patients.

Brief summary: Kidney transplantation is the treatment of choice for ESRD. However, the life expectancy of kidney transplant patients is lower than that of the general population. Deaths recipients are due mainly to cardiovascular diseases related to a chronic inflammatory state. In addition, renal transplant patients frequently have anemia, identified as an independent cardiovascular risk factor that can be corrected by blood transfusion.

But the relationship between transfusion and inflammatory condition are bidirectional. The patient's inflammatory condition will sound on the effectiveness of transfusion and transfusion could trigger an inflammatory condition. This has been reported with the said blood components "aged", especially with packed red cells in patients hospitalized in intensive care after heavy heart surgery.The main objective of this study is to evaluate the impact of early transfusions on the evolution of renal transplantation (ie death, anti-HLA immunization, acute rejection, graft loss, delayed graft function, cardiovascular events ) taking into account in the analysis: patient age at the time of transplantation, the number of incompatibility (s) (HLA class I and / or II) between the graft and the patient and sex of the recipient.

This is a multicenter retrospective observational study (descriptive epidemiological study).The impact of early transfusions is determined retrospectively over a period of 6 years from 01 January 2002 to 31 December 2008, in renal transplant patients of all centers of France met the criteria for inclusion. This cohort represents about 12 000-14 000 patients


Eligibility criteria: Inclusion Criteria:

* male or female patients aged over 18 years
* patients who received a first kidney transplant

Exclusion Criteria:

* Patients who received multiple transplants.

Primary outcomes:
measure: blood transfusion carried out within 14 days of transplantation (presence / absence) related to renal transplantation changes (i.e.: death, anti-HLA immunization, acute rejection, graft loss, delayed recovery of renal function, cardiovascular events)
timeFrame: 6 years
Secondary outcomes:
measure: blood transfusion carried out within 14 days of transplantation, taking into account the shelf life of CGR transfused, number of pockets transfused and the number of transfusion events related to renal transplantation changes.
timeFrame: 6 years
Other outcomes:
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Study officials:
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