Disorder Related to Renal TransplantationORBITNCT02841111
Old Red Blood Cell In Renal Transplantation
An observational study of Disorder Related to Renal Transplantation and Transfusion Reaction, run by Centre Hospitalier Universitaire de Besancon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder Related to Renal Transplantation, Transfusion Reaction
- How many people
- 12,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- male or female patients aged over 18 years
- patients who received a first kidney transplant
Who cannot join
- Patients who received multiple transplants.
About this study
Official title: 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
- Medical subject headings
- Transfusion Reaction
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJan 2002
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841111
- Sponsor's protocol ID
- P/2013/166
- Acronym
- ORBIT
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2016
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Transfusions of Packed Red Cells on the Evolution of Renal Transplantation
- ClinicalTrials.gov ID
- NCT02841111
- Acronym / sponsor ID
- ORBIT / P/2013/166
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- 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
- Study start
- Jan 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- male or female patients aged over 18 years
- patients who received a first kidney transplant
Key exclusion criteria (1 listed)
- Patients who received multiple transplants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder Related to Renal Transplantation and Transfusion Reaction, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.