- Was there a reference that needed to be followed for procuring the lungs for this study?
- Who was responsible for transportation arrangements to and from LBE facilities?
- How should the lungs be packaged for transport to LBE facilities?
- Was research authorization required for donor lungs in your clinical trial?
- Did the OPO receive updates on lungs sent for EVLP?
- Could donor lungs be allocated to two different centers?
- What happened when EVLP was completed and the requesting transplant center declined the lung(s)?
Was there a reference that needed to be followed for procuring the lungs for this study?
There was no protocol requirements for to the way that the lungs are procured. However, we had 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
Who was responsible for transportation arrangements to and from LBE facilities?
The transplant center and/or OPO was responsible for local ground transportation at LBE. If for whatever reason transportation arrangements could not be made expeditiously, Lung Bioengineering was able to assist in air and ground transportation logistics. The EVLP Specialist was in contact with the coordinator at all times to ensure that lungs destined for LBE facilities got 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
DownloadWas research authorization required for donor lungs in your clinical trial?
Our protocol required authorization/consent for research and transplantation as specified in each state’s Uniform Anatomical Gift Law.
Did 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). The OPO was then notified by Lung Bioengineering staff of the transplant center disposition.
Could donor lungs be allocated to two different centers?
Yes. It was 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 happened when EVLP was completed and the requesting transplant center declined the lung(s)?
If EVLP demonstrated that the lung(s) were suitable for transplantation and the requesting center declined them, the host OPO was notified. There were circumstances when the OPO had the option to place the lungs with another program participating in the EVLP study. All allocation was completed by the host OPO. Lungs that were not approved for transplant were referred back to the organ procurement organization for final disposition.