Immune Function Following Liver Transplantation

Liver Transplant; Complications Clinical Trial

— SEPTIFOIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302246
• Other study ID #: NI 11055
• Status: Completed
• Start date: January 8, 2016
• Est. completion date: December 17, 2019

Study information

• Verified date: December 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant; Complications

Intervention

Genetic:
• Biological 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune functionnal profile	quantitative monocytes mHLA-DR measurment	pre-operatively