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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Not yet enrolling

Conditions: Lung Graft Dysfunction

Treatments: Procedure: Blood collection 6 months; Procedure: Blood collection T0

Study type: Interventional

Funder types: Other

Identifiers

NCT06113224

RCAPHM22_0448

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Control patients

Active Comparator group

Description:

Patients with an indication for cardiac surgery with extracorporeal circulation but without homograft

Treatment:

Procedure: Blood collection 6 months

Procedure: Blood collection T0

Lung homograft patients

Experimental group

Description:

patients requiring lung homograft implantation

Treatment:

Procedure: Blood collection 6 months

Procedure: Blood collection T0