NCT06113224

Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Graft Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Blood collection T0	2 blood samples will be taken in addition to the pre-operative check-up.
PROCEDURE	Blood collection 6 months	1 blood sample will be taken 6 months after surgery.

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2023-11-02
• Last updated: 2023-11-02