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Completed

NCT Number: NCT02841111

Old Red Blood Cell In 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who received multiple transplants.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Agence de La Biomédecine
  • Amiens University Hospital
  • Bicetre Hospital
  • CHU de Reims
  • CHU de Rouen - Accueil
  • CRC CHI Creteil France
  • Central Hospital, Nancy, France
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire Dijon
  • Centre Hospitalier Universitaire de Nice
  • Centre Hospitalier Universitaire de Saint Etienne
  • Etablissement Français du Sang
  • Groupe Hospitalier Pitie-Salpetriere
  • Hopital Foch
  • Hôpital Edouard Herriot
  • 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

Registry information

Official study title

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

Acronym: ORBIT

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Jul 22, 2016
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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