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This study will determine if primary graft dysfunction (which causes low blood oxygen levels and fluid or inflammation in the lungs) after lung transplant can be prevented through the use of the study drug (IL-1 receptor antagonist, Anakinra). In this study, lung transplant participants who are randomized to the treatment group will have the study drug injected into the solution that their donor lungs are kept in prior to transplant.
After being informed about the study and potential risks, all patients giving written consent who undergo a lung transplant will be randomized in a 1:1 ratio to either the treatment or control group. Patients randomized to the treatment group will have one dose of the study drug, Anakinra, injected into the perfusion solution that their donor lungs are kept in just prior to lung transplant. Both groups will receive standard lung transplant care after implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group: Anakinra during EVLP | Experimental | One dose (100mg) Anakinra will be injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant. |
|
| Control group | No Intervention | Control group will not receive Anakinra during EVLP. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra | Drug | 100 mg injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary graft dysfunction after lung transplant | Occurrence of primary graft dysfunction after lung transplant on post-operative day 3, measured by arterial blood gas blood tests and chest X-rays. | 3 days post lung transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU stay post lung transplant, assessed up to one year post transplant | Length of intensive care unit stay post lung transplant | Days post lung transplant up to 52 weeks |
| Length of hospital stay post lung transplant, assessed up to one year post transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Carns, MS | Contact | 312-503-1137 | m-carns@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chitaru Kurihara, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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Length of hospital stay post lung transplant |
| Days post lung transplant up to 52 weeks |
| Length of ventilator use post lung transplant, assessed up to one year post transplant | Length of ventilator use post lung transplant | Days post lung transplant up to 52 weeks |
| Survival after lung transplant | 30 days, 90 days, and one year survival status after lung transplant | 30 days, 90 days and one year post lung transplant |
| D011506 | Proteins |
| D001685 | Biological Factors |