Old Red Blood Cell In Renal Transplantation

Disorder Related to Renal Transplantation Clinical Trial

— ORBIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841111
• Other study ID #: P/2013/166
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: July 19, 2016
• Start date: January 2002
• Est. completion date: December 2008

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Disorder Related to Renal Transplantation
• Transfusion Reaction

Locations

Country	Name	City	State
n/a

Sponsors (35)

Lead Sponsor

Collaborator

Centre Hospitalier Universitaire de Besancon

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No