Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion

N/ANot Yet RecruitingNCT06113224

Assistance Publique Hopitaux De Marseille53 enrolled

Overview

This is a prospective, monocentric, observational cohort study whose main objective is to describe the number and rate of patients who developed DSAs (Donor Specific Antibody) at 6 months post-surgery with implantation of a cryopreserved lung homograft.

Lung homograft is used in a large number of complex malformations. It is accepted that homografts may induce immune reactions in the recipient, but no immunological studies have been carried out to characterize the recipient's immune reactions to the homograft and their potential impact on valve function. In this project, the authors propose to study the immunizing character of cryopreserved lung homografts by identifying the appearance of antibodies directed against the HLA, DSA (Donor Specific Antibodies) molecules of the graft (lung homograft) at 1 month and 6 months after its surgical implantation.The primary objective will be analyzed by describing the rate of patients who developed DSA at 6 months post-surgery with implantation of a cryopreserved lung homograft.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Lung Graft Dysfunction

Interventions

Blood collection T0PROCEDURE

2 blood samples will be taken in addition to the pre-operative check-up.

Blood collection 6 monthsPROCEDURE

1 blood sample will be taken 6 months after surgery.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteriafor control patients: * Patient receiving a cryopreserved pulmonary valve homograft * Patient aged 14 or over * Signature of consent by adult patients/parents/guardians and assent by children Inclusion Criteriafor patients with lung homograft : * Patientsreceiving a cardiac surgery with extracorporeal circulation and without lung homograft Exclusion Criteria for both group * Emergency surgery patient * Pregnant women or childbirth within the last 6 months * Transfusion during the surgery or within the last 6 months * Patient with DSAs detected before the surgery * Patient with anti-HLA antibodies (non-DSAs) detected before the surgery

Outcomes

Primary Outcomes

Detection of DSA at 6 months

Luminex® detection of DSA at 6 months after lung homograft implantation

Time frame: 6 months

Secondary Outcomes

DSA Quantification

DSA will be quantified in patients who developed DSA 6 months after lung homograft implantation

Time frame: 6 months

antibody anti-HDLA (non DSA) detection

Detection or non-detection of non-DSA anti-HLA antibodies will be assessed by Mean Fluorescence Intensity.

Time frame: 6 months

Early degeneration of the homograft

The early degeneration of the homograft will be defined by the occurrence of at least one of the following criteria: * Need to replace lung homograft * Need for dilatation during catheterization of lung homografts * Maximum gradient across the lung homograft ≥ 30mmhg on echography at 6 months * Pulmonary insufficiency ≥ moderate on echography at 6 months

Time frame: 6 months

Central Contacts

Marien Lenois, PhD

CONTACT

+33 491386000 marien.lenoir@ap-hm.fr

Clement PIERRE, PhD

CONTACT

+33 491435796 clement.pierre@ap-hm.fr

Data from ClinicalTrials.gov

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