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Interest of the Donor-specific Antibodies After Liver Transplantation

Completed
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
Inclusion Criteria
  • 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
Exclusion Criteria
  • Minor patients.
  • Pregnant women or during lactation.
  • Patient under curatorship.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Prevalence DSA positivity (or anti-HLA).At baseline

The positivity is defined as a fluorescence ≥ 1000.

Secondary Outcome Measures
NameTimeMethod
Presence of C1q binding-complement anti-HLA antibodiesat 3 months, 1 year and 2 years after transplantation
Fluorescence quantificationat 3 months, 1 year and 2 years after transplantation

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez

🇫🇷

Lille, France

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