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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control patients | Active Comparator | Patients with an indication for cardiac surgery with extracorporeal circulation but without homograft |
|
| Lung homograft patients | Experimental | patients requiring lung homograft implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection T0 | Procedure | 2 blood samples will be taken in addition to the pre-operative check-up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of DSA at 6 months | Luminex® detection of DSA at 6 months after lung homograft implantation | 6 months |
| 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. |
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Inclusion Criteriafor control patients:
Inclusion Criteriafor patients with lung homograft :
Exclusion Criteria for both group
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marien Lenois, PhD | Contact | +33 491386000 | marien.lenoir@ap-hm.fr | |
| Clement PIERRE, PhD | Contact | +33 491435796 | clement.pierre@ap-hm.fr |
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| Blood collection 6 months | Procedure | 1 blood sample will be taken 6 months after surgery. |
|
| 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:
| 6 months |