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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL128492-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to see if adding a drug called Regadenoson to the EVLP circulation reservoir during perfusion of marginal donor lungs will help increase the likelihood that the donor lungs will become usable for transplantation.
Lung transplantation currently is one way to treat a variety of serious diseases and conditions such as emphysema, pulmonary fibrosis, and cystic fibrosis. Ischemia Reperfusion Injury (IRI) is a known problem that can happen during the first few days after a lung transplant. IRI can cause swelling of the lungs and low levels of oxygen. The most serious type of IRI can cause the transplanted lung to not work properly, it can even cause death. While new treatments and practices have been put into place to lower the chances of IRI, it is still a difficult problem to overcome after a lung transplant.
Molecule called Adenosine 2A receptor (A2AR) have been studied in animals with IRI for many years. Some of these studies suggest that with the use of A2AR agonist, the chance of IRI may be lowered or prevented. Regadenoson is a selective A2AR agonist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVLP with Regadenoson | Experimental | Following the routine retrieval procedure of the lungs, they will be placed on the EVLP circuit (XVIVO Perfusion System) and infused with the study drug, Regadenoson. |
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| EVLP with Steen solution | Placebo Comparator | Following the routine retrieval procedure of the lungs, they will be placed on the EVLP circuit (XVIVO Perfusion System) and infused with the same volume of Steen solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | If the donor lungs are randomized the experimental arm, the administration of Regadenoson will be performed at each study site by a qualified medical professional. The donor lungs will be perfused with Regadenoson at a dosage of 1.44 microgram/kg/min (based on donor's weight) for a minimum of three hours and maximum of four hours, using a pediatric syringe pump into the EVLP circuit (XVIVO Perfusion System). The infusion will begin within 10 minutes of the start of the EVLP procedure. Once the EVLP is complete the lungs are re-flushed with Perfadex solution (removing the Steenâ„¢ solution and Regadenoson; standard for EVLP). |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Rehabilitation | The primary endpoint is rehabilitation (yes, no) for marginal donor lungs that undergo ex-vivo perfusion using a "lung box" as assessed by the transplant surgeon and utilizing the "Toronto Method" clinical protocol. Rate of rehabilitation is defined as the proportion of sets of lungs that underwent EVLP with/without Regadenoson treatment and are determined to be eligible for implant. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Lung Graft Dysfunction (PGD) Score | Primary graft dysfunction (PGD) is a clinical entity that reflects the development of early acute lung injury after lung transplantation. PGD severity is graded between 0 and 3 and it is measured at 6h, 12h, 24h, 48h and 72 hours after lung transplantation. A score of Score 0 means no PGD and 1-3 increasingly more severe. 3 is so severe requires ECMO support. |
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Inclusion Criteria:
Donor Lung Inclusion Criteria for EVLP
At the time of clinical evaluation, the PaO2/FiO2 ≤ 300mm Hg OR
If the PaO2/FiO2 is > 300mm hg and the donor has any one of more of the following donor risk factors:
Donor lung Inclusion Criteria for Transplant Suitability after EVLP
Participant Inclusion Criteria
Exclusion Criteria:
Donor Lung Exclusion Criteria for EVLP
Donor Lung Exclusion Criteria for Transplant Suitability after EVLP (All of the below must be negative)
Participant Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Christine Lau, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States | ||
| Cleveland Clinic |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
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Randomization to the EVLP with placebo or EVLP with Regadenoson groups will be performed in a 1:2 ratio.
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All study team members and subjects will be blinded to treatment assignment with the exception of the statisticians and investigational pharmacist preparing the study treatment.
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| Placebo | Drug | If the donor lungs are randomized to the Steen solution arm, the donor lungs will be perfused with placebo at a rate equivalent to the dosage of Regadenoson (1.44 microgram/kg/min), for a minimum of three hours and maximum of four hours, using the same pediatric syringe pump. The infusion will begin within 10 minutes of the start of the EVLP procedure. |
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| 72 hours |
| Intensive care unit length of stay | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | 8 weeks |
| Using of ECMO | How often the patient will use ECMO due to lung infection after lung transplantation | 1 week |
| Duration on ventilator post-Operative | Will measure how long the patient use ventilator post-operation. | 1 month |
| 12-month survival | Patient survival 360 days after lung transplantation | 12 months |
| Cleveland |
| Ohio |
| 44195 | |
| United States |