Interest of the Donor-specific Antibodies After Liver Transplantation

Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03238443

Acronym

vaLIDLIver

Enrollment

120

Registered

2017-08-03

Start date

2016-02-16

Completion date

2019-07-13

Last updated

2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant

Keywords

DSA

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©)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Prevalence DSA positivity (or anti-HLA).	At baseline	The positivity is defined as a fluorescence ≥ 1000.

Secondary

Measure	Time frame
Fluorescence quantification	at 3 months, 1 year and 2 years after transplantation
Presence of C1q binding-complement anti-HLA antibodies	at 3 months, 1 year and 2 years after transplantation

Countries

France

Outcome results