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

NCT03997253 | Recruiting

• 1 other identifier: 87RI18-0027
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Organ Transplantation

Keywords

organ transplantation, graft, biological collection.

Outcome Measures

Primary Outcomes (1)

• Survival of the graft

  12 months

Study Arms (1)

blood, bile and urine samples

EXPERIMENTAL

blood and urine samples at D0,D1, D3 D7, D14, M1, M3, M6 and M12

Other: blood and urine samples

Interventions

blood and urine samples OTHER

various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection

blood, bile and urine samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Limoges: lead
• University Hospital Federation FHU SUPORT: collaborator

Study Sites (4)

Limoges hospital

Limoges, France

RECRUITING

Poitiers Hospital

Poitiers, 86000, France

RECRUITING

Rennes Hospital

Rennes, 35000, France

NOT YET RECRUITING

Tours hospital

Tours, 37000, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Sophie ALAIN, MD

CONTACT

+33 5 55 056 728; sophie.alain@unilim.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: various blood and urine samples will be collected from the recipient at D0, D1, D3, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection ancillary studies : stools at D0 D7 M1 and M3 will be collected for liver transplant patient

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 25, 2019
• Study Start: December 21, 2020
• Primary Completion: February 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)