Transplant Trial Watch

Comparison of lung preservation solutions in human lungs using an ex vivo lung perfusion experimental model.

Medeiros IL, Pego-Fernandes PM, et al.

Clinics 2012; 67(9): 1101-1106.


Aims
To compare the efficacy of two lung preservation solutions in an ex vivo lung perfusion study.

Interventions
Perfadex versus LPDnac. An ex vivo lung perfusion system was used, and lungs were ventilated and perfused after 10 hours of cold ischemia.

Participants
16 human lungs from brain-dead donors that were rejected by pulmonary transplantation teams.

Outcomes
Outcomes included weight variation, oxygenation, capacity, pulmonary vascular resistance, pulmonary compliance and the Lung Injury Score which was the sum of the following parameters: interstitial edema, alveolar edema, arterial thickening, vascular thrombosis, interstitial fibrosis, alveolar fibrin, alveolar exudate, alveolar hemorrhage, interstitial hemorrhage, inflammatory interstitial infiltrate, pneumocystis, alveolar macrophages and necrosis.

Follow-up
Biopsies were collected during organ harvesting and after 10 hours of cold ischemia.

CET Conclusions
This is primarily a demonstration of an ex vivo isolated lung perfusion model. The study used 16 deceased donor lungs that were rejected by transplant teams (8 in each arm of the study). A small, non-inferiority study design was used although it is not clear on which outcome this design was based. The cold-preservation solution Perfadex was compared to LPDnac, a Brazilian-manufactured equivalent. Results were comparable between the two groups after ex-vivo perfusion including weight gain, oxygenation capacity, pulmonary vascular resistance and histological analysis.

Jadad score
1

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
Not reported

Funding source
Industry & non-industry funded