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Old Red Blood Cell In Renal Transplantation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02841111
Acronym
ORBIT
Enrollment
12000
Registered
2016-07-22
Start date
2002-01-31
Completion date
2008-12-31
Last updated
2016-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder Related to Renal Transplantation, Transfusion Reaction

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

Interventions

None listed

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients who received multiple transplants.

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026