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Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.
The purpose of this continuation study is to collect five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System. The EXPAND Lung trial results have been presented and have shown positive results in the use of expanded criteria donor lungs and patient follow-up, post-transplant. The current study is being conducted to continue to collect follow-up on participants in the EXPAND study, in order to evaluate long-term patient survival status and BOS diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Expand Trial Cohort | All patients previously enrolled in the EXPAND Lung trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS Lung System | Device | Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 2 years |
| Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 3 years |
| Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 4 years |
| Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 5 years |
| Presence or absence of bronchiolitis obliterans sydrome (BOS) | Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider. | 2 years |
| Presence or absence of bronchiolitis obliterans sydrome (BOS) | Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider. | 3 years |
| Presence or absence of bronchiolitis obliterans sydrome (BOS) | Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients previously enrolled in the Expand Lung trial who received lungs preserved on the OCS Lung System.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| University of California at Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40686680 | Derived | Loor G, Warnecke G, Villavicencio MA, Smith MA, Zhou X, Kukreja J, Ardehali A, Hartwig MG, Daneshmand MA, Hertz MI, Huddleston SJ, Haverich A, Madsen JC, Neyrinck A, Van Raemdonck D. Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantation. EClinicalMedicine. 2025 Jul 8;85:103334. doi: 10.1016/j.eclinm.2025.103334. eCollection 2025 Jul. |
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| Presence or absence of bronchiolitis obliterans sydrome (BOS) | Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider. | 5 years |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Hospitals Leuven | Leuven | 3000 | Belgium |
| Hannover Medical School | Hanover | D-300625 | Germany |