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Immune Function Following Liver Transplantation

Immune Functional Profile as Predictor of Infective Complications Following Pediatric Liver Transplantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04302246
Acronym
SEPTIFOIE
Enrollment
61
Registered
2020-03-10
Start date
2016-01-08
Completion date
2019-12-17
Last updated
2020-03-10

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

Conditions

Liver Transplant; Complications

Brief summary

Post-operative care following liver transplantation is characterized by a high incidence of infective and immunological complications. Restauration of liver function following liver transplantation is progressive and characterize a period of immuno-infective vulnerability. The purpose of this study is to characterize the early post-operative immune function in children after liver transplantation.

Detailed description

Within a few decades, liver transplantation has become an effective treatment of end-stage liver diseases associated with high spontaneous mortality. However, the consequences of immediate transplants are frequently complicated by infective (nosocomial infection) and immunological complications (acute graft rejection) in up to 40 to 60% of liver transplanted patients. In order to ensure graft immunotolerance, immunosuppressive therapy based mainly on calcineurin inhibitors, is initiated soon after liver transplantation. Immunosuppressive therapy is intended to reduce the response of cytotoxic lymphocytes and NK cells. As a result, an important component of the immune response is blocked. In addition, function of the transplanted liver, which is a key organ for both immuno-inflammatory signalling and host defense against pathogens, is progressively restored post-operatively. Thus in this post-transplant period, there is a critical period where liver function is severly impaired and progressively get restaured. The aim of this study is to characterize the restauration of immune function in the early post-operative period and evaluate its correlation with occurence of infective or immunological complications.

Interventions

GENETICBiological testing on sequential blood sample

Biological characterization of various immune function and blood circulating leukocytes phenotyping before liver transplantation and therafter at day-3, -7, -14 postoperatively and if septic complication occurs.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

* Child under 18 admitted for liver transplantation * Signature of consent by the two holders of parental authority. * Informing children as far as their age and condition allow. * Affiliation to a social protection

Exclusion criteria

* Children under 6 kg * Children transplanted for primary graft dysfunction * Children scheduled for liver-kidney transplants

Design outcomes

Primary

MeasureTime frameDescription
Immune functionnal profilepre-operativelyquantitative monocytes mHLA-DR measurment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026