If you work for an organ procurement organization, please read over the following list of frequently asked questions. We hope that these will explain the process and provide a jumping off point for your organization to get involved.
Q: Is there a protocol that needs to be followed for procuring the lungs for this study?
There are no changes to the way that the lungs are procured. However, we do have a “Lung Retrieval and Preservation for EVLP” protocol that has recommendations for best practices for lung retrieval specifically for EVLP. It is recommended to review this protocol and to share it with your colleagues who perform the lung retrieval. Technique of Lung Retrieval and Preservation for EVLP
Q: Who is responsible for transportation arrangements to and from LB-1?
The transplant center and/or OPO is responsible for all transportation arrangements. If for whatever reason transportation arrangements cannot be made expeditiously, Lung Bioengineering is able to assist in air and ground transportation. The EVLP Specialist will be in contact with the coordinator at all times to ensure that lungs destined for LB-1 gets there as quickly as possible no matter who made the arrangements.
Q: How should the lungs be packaged for transport to LB-1?
Lungs should be packaged according to OPTN policy.
Q: Is research consent required for donor lungs in your clinical trial?
The study protocol requires authorization/consent for research and transplantation as specified in each states’ Uniform Anatomical Gift Act.
Q: 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. The OPO is then notified by Lung Bioengineering staff of the transplant center disposition.
Q: Can donor lungs be allocated to two different places?
Yes. It is possible for two lungs from a single donor to be EVLP en bloc at LB-1, separated and sent to intended recipients at two different clinical trial sites.
Q: 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 and they will have the option to place the lungs with another program participating in the EVLP study (in rank order according to OPTN allocation policy). All allocation is to be completed by the host OPO.