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Single-arm, prospective observational study
This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood samples | Diagnostic Test | For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein. |
| Measure | Description | Time Frame |
|---|---|---|
| Donor-specific Antibodies Clearance | The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end. | 6, 12, 18, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Graft survival | Graft survival is defined as freedom from mortality and re-transplantation | 1, 3, 5 years |
| Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD) |
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Inclusion Criteria:
Exclusion Criteria:
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All patients after lung transplantation with detection of donor-specific antibodies
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| Name | Affiliation | Role |
|---|---|---|
| Fabio Ius, Dr. | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery | Hanover | Germany |
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| 1, 3, 5 years |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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