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

Organ Transplantation Clinical Trial

— BIOSUPORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03997253
• Other study ID #: 87RI18-0027
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: University Hospital, Limoges
• Contact: Sophie ALAIN, MD
• Phone: +33 5 55 056 728
• Email: sophie.alain[@]unilim.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: November 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Organ Transplantation

Intervention

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

Locations

Country	Name	City	State
France	Limoges hospital	Limoges
France	Poitiers Hospital	Poitiers
France	Rennes Hospital	Rennes
France	Tours hospital	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	University Hospital Federation FHU SUPORT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of the graft		12 months