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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Graft Dysfunction
• Intervention / Treatment: Procedure: Blood collection T0; Procedure: Blood collection 6 months

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 Type: Interventional
• Enrollment (Estimated): 53
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marien Lenois, PhD; Phone Number: +33 491386000; Email: marien.lenoir@ap-hm.fr
• Study Contact Backup: Name: Clement PIERRE, PhD; Phone Number: +33 491435796; Email: clement.pierre@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control patients; Patients with an indication for cardiac surgery with extracorporeal circulation but without homograft	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.
Experimental: Lung homograft patients; patients requiring lung homograft implantation	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RCAPHM22_0448

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No