Enhancing Kidney Function with Thrombolytic Therapy following Donation after Cardiac Death: A Multicenter Quasi-Blinded Prospective Randomized Trial.
Woodside KJ, Goldfarb DA, et al.Clinical Transplantation 2015 [record in progess].
Aims
To determine kidney function when utilizing thrombolytic tissue plasminogen activator (tPA) during machine pulsatile perfusion (MPP) in donation after cardiac death (DCD) kidneys
Interventions
A kidney from each recovered kidney pair was prospectively randomized to receive tPA (50 mg Alteplase) or no tPA (control) in the MPP perfusate.
Participants
24 kidneys from 19 DCD kidney donors were enrolled in the study
Outcomes
The primary outcome measured was delayed graft function (DGF). Other outcomes measured were glomerular filtration rate (GFR) and allograft failure.
Follow-up
Median follow-up was 761 days, with all surviving patients having a minimum of 1 year of follow-up.
CET Conclusions
The study did not reach its target inclusion (29 donors versus 49 donors) and therefore was not adequately powered, despite the rather optimistic reduction in DGF that was speculated (30% versus 60%). The study found that tPA applied during hypothermic machine perfusion did not reduce the rate of DGF in kidneys retrieved from donation after circulatory death (DCD III). There is not a lot of evidence regarding the activity of tPA at the low temperatures used in this study and this may also have affected the results. Unfortunately the statistical analysis could not really make use of the paired design given the small numbers included. There were no significant differences seen in PNF, graft survival, GFR or early blood loss. The study was adequately randomised and was as well blinded as could be expected of a study of this type.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT01197573