Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion

NCT ID: NCT06113224

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2027-06-30

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.

Conditions

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Lung Graft Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control patients

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

Group Type ACTIVE_COMPARATOR

Blood collection T0

Intervention Type PROCEDURE

2 blood samples will be taken in addition to the pre-operative check-up.

Blood collection 6 months

Intervention Type PROCEDURE

1 blood sample will be taken 6 months after surgery.

Lung homograft patients

patients requiring lung homograft implantation

Group Type EXPERIMENTAL

Blood collection T0

Intervention Type PROCEDURE

2 blood samples will be taken in addition to the pre-operative check-up.

Blood collection 6 months

Intervention Type PROCEDURE

1 blood sample will be taken 6 months after surgery.

Interventions

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Blood collection T0

2 blood samples will be taken in addition to the pre-operative check-up.

Intervention Type PROCEDURE

Blood collection 6 months

1 blood sample will be taken 6 months after surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient receiving a cryopreserved pulmonary valve homograft
* Patient aged 14 or over
* Signature of consent by adult patients/parents/guardians and assent by children


* Patientsreceiving a cardiac surgery with extracorporeal circulation and without lung homograft

Exclusion Criteria

* 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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Marien Lenois, PhD

Role: CONTACT

+33 491386000

Clement PIERRE, PhD

Role: CONTACT

+33 491435796

Other Identifiers

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RCAPHM22_0448

Identifier Type: -

Identifier Source: org_study_id

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