Status:
NOT_YET_RECRUITING
Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Lung Graft Dysfunction
Eligibility:
All Genders
14+ years
Phase:
NA
Brief 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...
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 ch...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06113224
Start Date
December 1 2023
End Date
June 1 2027
Last Update
November 2 2023
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