Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management (BIOSUPORT)

March 28, 2024 updated by: University Hospital, Limoges

Increased indications for transplantation continue to worsen the shortage of organs and need the extension of graft sampling criteria and the search for new potential sources of organs. Despite undeniable success in the short term, due to major advances in surgery, medicine and research, transplant recipients continue to face the risk of chronic rejection and long-term complications.

The University Hospital Federation "FHU SUPORT" was created to optimize the chances of success of the organ transplant and improve the quality of life of the transplanted patient. FHU SUPORT 's ambition is based on a translational strategy that presents two priority areas:

Axis 1: Optimization, evaluation, conditioning of the donor, graft, recipient Axis 2: Personalized follow-up of the transplanted patient in the short and long term Identifying factors for long-term graft and patient survival through translational research from a common cohort and biological collection will predict transplant rejection, prolong graft function, or improve the patient's care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Limoges, France
        • Recruiting
        • Limoges Hospital
        • Contact:
        • Principal Investigator:
          • Véronique Loustaud-Ratti, MD
        • Principal Investigator:
          • Jean-Philippe Rerolle, MD
      • Poitiers, France, 86000
        • Recruiting
        • Poitiers Hospital
        • Principal Investigator:
          • Christine Silvain
        • Contact:
        • Principal Investigator:
          • Antoine Thierry
      • Rennes, France, 35000
        • Not yet recruiting
        • Rennes Hospital
        • Contact:
        • Principal Investigator:
          • Erwan Flecher
        • Principal Investigator:
          • Pauline Houssel-Debry
        • Principal Investigator:
          • Leonard Golbin
      • Tours, France, 37000
        • Recruiting
        • Tours Hospital
        • Contact:
        • Principal Investigator:
          • Ephrem Salame
        • Principal Investigator:
          • Matthias Buchler
        • Principal Investigator:
          • Christian Mirguet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female over 18 (no age limit)
  • affiliated to a social security organization
  • Recipient (s) of a kidney, liver or heart transplant
  • followed by at least one of the FHU SUPORT centers (Tours, Poitiers, Limoges, Rennes)
  • having given informed consent to participate in the cohort.

Exclusion Criteria:

  • Patient unable to understand the information given by the investigator
  • People under the protection of justice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: blood, bile and urine samples
blood and urine samples at D0,D1, D3 D7, D14, M1, M3, M6 and M12
Other: blood and urine samples
various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival of the graft
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Collaborators

University Hospital Federation FHU SUPORT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

June 24, 2019

First Submitted That Met QC Criteria

June 24, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 87RI18-0027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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