Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion

Lung Graft Dysfunction Clinical Trial

— CAssIOPé  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06113224
• Other study ID #: RCAPHM22_0448
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: June 2027

Study information

• Verified date: October 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Marien Lenois, PhD
• Phone: +33 491386000
• Email: marien.lenoir[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 53
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Graft Dysfunction

Intervention

Procedure:
• Blood collection T0
2 blood samples will be taken in addition to the pre-operative check-up.
• Blood collection 6 months
1 blood sample will be taken 6 months after surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of DSA at 6 months	Luminex® detection of DSA at 6 months after lung homograft implantation	6 months
Secondary	DSA Quantification	DSA will be quantified in patients who developed DSA 6 months after lung homograft implantation	6 months
Secondary	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
Secondary	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