Interest of the Donor-specific Antibodies After Liver Transplantation
- Conditions
- Liver Transplant
- Registration Number
- NCT03238443
- Lead Sponsor
- University Hospital, Lille
- Brief Summary
The study is a prospective observational mono center study
Primary objective :
Study the anti-HLA antibodies frequency preformed before liver transplantation and the kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver transplantation.
Secondary objective :
* Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology)
* Impact of DSA on:
* Graft and patients survivals
* Onset of allograft rejection (acute, late-onset, chronic)
* Unexplained liver graft dysfunction
* Unexplained liver enzymes abnormalities
* Liver fibrosis development (liver stiffness study using fibroscan©)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Liver transplanted patients older than 18, transplanted in Lille University Hospital.
- Written consent by the patient or his/her legal representative (especially patient with hepatic encephalopathy).
- Patients with health insurance
- Minor patients.
- Pregnant women or during lactation.
- Patient under curatorship.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence DSA positivity (or anti-HLA). At baseline The positivity is defined as a fluorescence ≥ 1000.
- Secondary Outcome Measures
Name Time Method Presence of C1q binding-complement anti-HLA antibodies at 3 months, 1 year and 2 years after transplantation Fluorescence quantification at 3 months, 1 year and 2 years after transplantation
Trial Locations
- Locations (1)
CHRU, Hôpital Claude Huriez
🇫🇷Lille, France