Old Red Blood Cell In Renal Transplantation (ORBIT)

Impact of Early Transfusions of Packed Red Cells on the Evolution of Renal Transplantation

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

Study Overview

• Status: Completed
• Conditions: Transfusion Reaction; Disorder Related to Renal Transplantation

• Study Type: Observational
• Enrollment (Actual): 12000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who received multiple transplants.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	6 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	6 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: University Hospital, Strasbourg, France; University Hospital, Angers; Centre Hospitalier Universitaire de Saint Etienne; Centre Hospitalier Universitaire Dijon; CHU de Reims; University Hospital, Montpellier; Hopital Foch; Central Hospital, Nancy, France; University Hospital, Bordeaux; Poitiers University Hospital; University Hospital, Clermont-Ferrand; Saint-Louis Hospital, Paris, France; University Hospital, Caen; Centre Hospitalier Universitaire de Nice; University Hospital, Limoges; University Hospital, Brest; University Hospital, Grenoble; Rennes University Hospital; University Hospital, Toulouse; University Hospital, Lille; Nantes University Hospital; Groupe Hospitalier Pitie-Salpetriere; Hôpital Edouard Herriot; Etablissement Français du Sang; University Hospital, Tours; Centre Hospitalier Lyon Sud; Agence de La Biomédecine; Amiens University Hospital; Bicetre Hospital; University Hospital, Marseille; Tenon Hospital, Paris; Hôpital Necker-Enfants Malades; CHU de Rouen - Accueil; CRC CHI Creteil France

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Estimate): July 22, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction
• Other Study ID Numbers: P/2013/166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO