Liver Transplantation Clinical Trial
— DSATHOfficial title:
Immunization Anti HLA in the Liver Transplant Recipients (DSATH)
Verified date | September 2019 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Anti HLA alloimmunization against the donor evaluated by the detection of anti-donor specific
antibodies (DSA) is an underestimated factor in liver transplantation and may contribute to
dysfunction and graft loss , especially among candidates for retransplantation, that have
major immunization.
This study will analyzed immunization markers at the time of liver retransplantation and
systematically in patients follow-up. This will allow to characterize the histological
lesions due to humoral immunization, to establish further investigations and to adapt early
immunosuppressive therapy.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years with no upper age limit, - Candidate for a liver retransplantation, whatever the indication, the period or the number of retransplantation - Recipient of a social protection scheme or entitled - Signature of informed consent Exclusion Criteria: - HIV positive patient, - Multi-organ transplantation. |
Country | Name | City | State |
---|---|---|---|
France | Unité Médicale de Transplantation Hépatique In Service d'Hépato-Gastro-Entérologie | Päris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Risk of graft failure at 24 months (Odds Ratio) depending on the presence of DSA at retransplantation. | The graft failure is defined by abnormal hepatic tests (AST, ALT, GGT, PAL, total and conjugated bilirubin, PT, INR), and/or abnormal hepatic histology , and/or abnormal hepatic imagery. | 24 months after retransplantation | |
Secondary | Evaluate the association between the presence of the DSA at retransplantation and histological abnormalities of the explant and graft. ( Pearson's chi-square test or Fischer exact test). | The DSA will be detected by a luminex technology and the positivity will be mesurated by the mean fluorescence intensity. Histological findings of the explant associated with anti HLA immunization will be described and clustered by the approach proposed by Lefaucheur et al (34), the analysis of C4d is conducted. The histological abnormalities graft will be evaluated from biopsies performed at 12 and 24 months. |
retransplantation, 12 and 24 months after retransplantation | |
Secondary | Evaluate the association between the presence of the DSA at before retransplantation and biological abnormalities graft from the previous donor | 9 months, 6 months, 3 months Before transplantation | ||
Secondary | Evaluate the association between the presence of the DSA at retransplantation and biological abnormalities graft at 1, 3, 12 and 24 months.( Pearson's chi-square test or Fischer exact test). | The presence of abnormality will be determined from the AST, ALT, GGT, PAL, total and conjugated bilirubin, PT, INR. | 1, 3, 12 and 24 months after retransplantation | |
Secondary | Evaluate the association between the presence of DSA and fibrosis Fibroscan measured at 12 and 24 months. (Student t-test or non parametric test). | 12 and 24 months after retransplantation | ||
Secondary | Evaluate the association between the number of acute rejection episodes and the presence of the DSA at retransplantation and their evolution (especially of recurrence).(Pearson's chi-square test or Fischer exact test). | 24 months after retransplantation |
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