Transplant Trial Watch

Transplant suitability of rejected human donor lungs with prolonged cold ischemia time in low flow acellular and high flow cellular ex vivo lung perfusion systems.

Okamoto, T., Wheeler, D. et al. (2019).

Transplantation; 12: 12.


Aims
This study aimed to investigate the transplant suitability of lungs with a prolonged cold ischaemia time (CIT) in two ex vivo lung perfusion (EVLP) systems and to investigate the difference between the two EVLP systems.

Interventions
Rejected lung donors with a prolonged CIT of 13.8 hours were randomized to either low flow acellular or high flow cellular EVLP systems (n=8 per system).

Participants
Rejected lung donors were obtained from the period of January 2012 and February 2014 (n=16).

Outcomes
The primary outcome being measured was transplant suitability, which was assessed using a number of parameters which were in accordance of the standard criteria of each EVLP systems. Transplant suitability was measured using the left atrium PaO2/FiO2 (P/F) ratio (< 400mmHg in the low flow acellular system and < 300 mmHg in the high flow cellular system were considered unsuitable for transplantation); airway parameters; final flow; airway fluid or abnormal visual findings, such as lung oedema or haematoma following perfusion. Lung tissues analysis was also measured using wet/dry ratios and path

Follow-up
N/A

CET Conclusions
The study aimed to compare the transplant suitability of lungs with prolonged cold ischaemia time (>8 hours) that were rejected for transplantation for two ex vivo lung perfusion (EVLP) systems. Sixteen donor lungs that were rejected by clinical staff, and/or had a PaO2/FiO2 (P/F) ratio <300 mmHG, and/or an abnormal chest X-ray showing infiltrates in lower lung fields were included. Lungs were randomised to perfusion with a low flow acellular or high flow cellular EVLP system but no details of the randomisation process were described. The mean CIT of lungs was 13.8 (9-19.5) hours. The high flow cellular system showed a significantly lower P/F ratio and higher vascular pulmonary resistance than the low flow acellular system. Transplant suitability was determined by two assessors although it was not clear whether each lung was assessed by two independent reviewers. In the low flow acellular group 3/8 lungs were considered transplantable versus none in the high flow cellular group.

Jadad score
3

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
None

Funding source
Non-industry funded