Lung Transplant Specimen Repository and Data Registry Protocol
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2013 |
| Start Date: | November 2005 |
| End Date: | December 2013 |
| Contact: | Karen Wood, MD |
| Email: | karen.wood@osumc.edu |
| Phone: | 614-293-4978 |
All patients enrolled in the registry will be recipients of single and double lung
transplantation (bilateral sequential, heart-lung, or living related donor grafts). During
the routine management of lung recipients frequent surveillance of the lung allograft is
necessary. This routinely involves: measurement of pulmonary functions, chest radiography,
collection of peripheral blood to assess other organ function and monitor therapeutic drug
levels, and bronchoscopic evaluation allowing for collection of lung lavage fluid and lung
tissue biopsy. This surveillance normally follows a set schedule during the first one to
two years following the transplant procedure. Surveillance is routinely performed at weeks
2, 8, 12, 24, 36, and 52 during the first year following the transplant procedure.
Additional surveillance may be performed at any time when clinically indicated for the
optimal management of the recipient. Information and specimens collected from each of these
encounters will be entered in the data registry and specimen repository.
The collection of disposable lung allograft (transplant tissue samples), blood samples and
information from medical records for storage, future analysis and research. Stored samples
will be available to other researchers who have obtained separate review and approval from
an ethics committee called an Institutional Review Board.
Immediately prior to the transplant surgery, the surgeon or pulmonologist will routinely
examine the lungs via bronchoscopy during which subjects will be medicated for pain.
The samples that are obtained during this and post-surgery (clinically scheduled)
bronchoscopies, including bronchial lavage, are either sent to pathology or are discarded if
they do not qualify to go to pathology. For this research, the researchers are asking that
the samples that do not qualify for pathology be placed into the repository instead of being
thrown away.
Inclusion Criteria:
- recipients of single and double lung transplantation (bilateral sequential,
heart-lung, or living related donor grafts).
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