Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion (CAssIOPé)

Conditions
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Lung Graft Dysfunction

Intervention / Treatment
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* Procedure: Blood collection T0
* Procedure: Blood collection 6 months


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control patients<br>Patients with an indication for cardiac surgery with extracorporeal circulation but without homograft | Procedure: Blood collection T0<br>* 2 blood samples will be taken in addition to the pre-operative check-up.<br>Procedure: Blood collection 6 months<br>* 1 blood sample will be taken 6 months after surgery.<br>|
| Experimental: Lung homograft patients<br>patients requiring lung homograft implantation | Procedure: Blood collection T0<br>* 2 blood samples will be taken in addition to the pre-operative check-up.<br>Procedure: Blood collection 6 months<br>* 1 blood sample will be taken 6 months after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of DSA at 6 months | Luminex® detection of DSA at 6 months after lung homograft implantation | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DSA Quantification | DSA will be quantified in patients who developed DSA 6 months after lung homograft implantation | 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. | 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 | 6 months |