- Is there a reference that needs to be followed for procuring the lungs for this study?
- Who is responsible for transportation arrangements to and from LBE facilities?
- How should the lungs be packaged for transport to LBE facilities?
- Is research authorization required for donor lungs in your clinical trial?
- Will the OPO receive updates on lungs sent for EVLP?
- Can donor lungs be allocated to two different centers?
- What happens when EVLP is complete and the requesting transplant center declines the lung(s)?
Is there a reference that needs to be followed for procuring the lungs for this study?
There are no protocol requirements for to the way that the lungs are procured. However, we do have a “Lung Retrieval and Preservation for EVLP” reference that has recommendations for lung retrieval specifically for EVLP.
• Long pulmonary artery
• Large left atrial cuff
• Long trachea
It is recommended to review and share with your colleagues who perform the lung retrieval.
Who is responsible for transportation arrangements to and from LBE facilities?
The transplant center and/or OPO is responsible for local ground transportation at LBE. If for whatever reason transportation arrangements cannot be made expeditiously, Lung Bioengineering is able to assist in air and ground transportation logistics. All transportation costs are covered by LBE. The EVLP Specialist will be in contact with the coordinator at all times to ensure that lungs destined for LBE facilities get there as quickly as possible no matter who made the arrangements.
How should the lungs be packaged for transport to LBE facilities?
Lungs should be packaged according to OPTN policy for unaccompanied organs and include tissue typing material and blood.
To purchase insulated containers for shipping, please visit https://www.fishersci.com/ (item number is SG-9W)
The OPTN policy can be accessed at the following address: https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf
INSULATED CONTAINERS FOR SHIPPING
(Safe Guard Technologies INSULTED FORM CONTAINER/WAX 4)
OPTN POLICY
DownloadIs research authorization required for donor lungs in your clinical trial?
Our protocol requires authorization/consent for research and transplantation as specified in each state’s Uniform Anatomical Gift Law.
Will the OPO receive updates on lungs sent for EVLP?
At the conclusion of the EVLP procedure, the study center must indicate the disposition of the lung (transplant or not transplant) in the client portal of the CMX. The OPO is then notified by Lung Bioengineering staff of the transplant center disposition.
Can donor lungs be allocated to two different centers?
Yes. It is possible for two lungs from a single donor to be sent for EVLP en bloc at LBE facilities, separated and sent to intended recipients at two different clinical trial sites.
What happens when EVLP is complete and the requesting transplant center declines the lung(s)?
If EVLP demonstrates that the lung(s) are suitable for transplantation and the requesting center declines them, the host OPO will be notified. There are circumstances when the OPO will have the option to place the lungs with another program participating in the EVLP study. All allocation is to be completed by the host OPO. Lungs that are not approved for transplant are referred back to the organ procurement organization for final disposition.