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Old Red Blood Cell In Renal Transplantation (ORBIT)

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ClinicalTrials.gov Identifier: NCT02841111
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Collaborators:
Agence de La Biomédecine
Etablissement Français du Sang
Amiens University Hospital
University Hospital, Angers
Bicetre Hospital
University Hospital, Bordeaux
University Hospital, Brest
University Hospital, Caen
University Hospital, Clermont-Ferrand
CRC CHI Creteil France
Centre Hospitalier Universitaire Dijon
Hopital Foch
University Hospital, Grenoble
Groupe Hospitalier Pitie-Salpetriere
University Hospital, Lille
University Hospital, Limoges
Hôpital Edouard Herriot
Centre Hospitalier Lyon Sud
University Hospital, Marseille
University Hospital, Montpellier
Central Hospital, Nancy, France
Nantes University Hospital
Hôpital Necker-Enfants Malades
Centre Hospitalier Universitaire de Nice
Poitiers University Hospital
CHU de Reims
Rennes University Hospital
CHU de Rouen - Accueil
Centre Hospitalier Universitaire de Saint Etienne
Saint-Louis Hospital, Paris, France
University Hospital, Strasbourg, France
Tenon Hospital, Paris
University Hospital, Toulouse
University Hospital, Tours
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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


Condition or disease
Disorder Related to Renal Transplantation Transfusion Reaction

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Study Type : Observational
Actual Enrollment : 12000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Impact of Early Transfusions of Packed Red Cells on the Evolution of Renal Transplantation
Study Start Date : January 2002
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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) [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 6 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02841111    
Other Study ID Numbers: P/2013/166
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Transfusion Reaction
Hematologic Diseases
Immune System Diseases