Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood collection T0, Blood collection 6 months.
- Who it may be relevant to
- Registry conditions: Lung Graft Dysfunction. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion (CAssIOPé)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Detection of DSA at 6 months [Time frame: 6 months]
Secondary outcome measures (3)
- DSA Quantification [Time frame: 6 months]
- antibody anti-HDLA (non DSA) detection [Time frame: 6 months]
- Early degeneration of the homograft [Time frame: 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06113224 · RCAPHM22_0448