Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion

Not Applicable

Not yet recruiting

• Conditions: Lung Graft Dysfunction
• Interventions: Procedure: Blood collection T0; Procedure: Blood collection 6 months

• Registration Number: NCT06113224
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

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 Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study First Posted: 2023-11-02
• Last Update Posted: 2023-11-02
• Study Start: 2023-12
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung homograft patients	Blood collection 6 months	patients requiring lung homograft implantation
Control patients	Blood collection T0	Patients with an indication for cardiac surgery with extracorporeal circulation but without homograft
Lung homograft patients	Blood collection T0	patients requiring lung homograft implantation
Control patients	Blood collection 6 months	Patients with an indication for cardiac surgery with extracorporeal circulation but without homograft

Primary Outcome Measures

Name	Time	Method
Detection of DSA at 6 months	6 months	Luminex® detection of DSA at 6 months after lung homograft implantation

Secondary Outcome Measures

Name	Time	Method
Early degeneration of the homograft	6 months	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
antibody anti-HDLA (non DSA) detection	6 months	Detection or non-detection of non-DSA anti-HLA antibodies will be assessed by Mean Fluorescence Intensity.
DSA Quantification	6 months	DSA will be quantified in patients who developed DSA 6 months after lung homograft implantation