Alteplase for blood flow restoration in hemodialysis catheters: a multicenter, randomized, prospective study comparing "dwell" versus "push" administration.

AIMS: Catheter-related thrombosis is a frequent complication of providing hemodialysis via central venous catheters. The primary aim of this study was to compare the efficacy of an alteplase "dwell" protocol over 30 minutes (with an additional 90 minutes where necessary) to a new 30 minute "push" protocol in restoring function to occluded hemodialysis catheters. METHODS: This was a prospective, randomized, parallel arm, multicenter study. Participants included hemodialysis patients using central venous catheters for vascular access. A new alteplase push protocol was the intervention and was compared to an alteplase dwell protocol. The primary outcome of this study was the proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a post thrombolytic blood flow ≥ 300 ml/ min. Secondary outcomes included recovery of Kt/V and liters processed per hour at the hemodialysis session following the intervention, time from thrombolytic to future catheter interventions, and the presence of serious adverse events. RESULTS: 82 patients were included in the intention-to-treat analysis. 65% (28/43) of catheters receiving the dwell protocol achieved blood flow ≥ 300 ml/min compared to 82% (32/39) in the push protocol. The difference was not statistically significant despite a 17% separation in the point estimates, p = 0.84. A non-significant result may have been associated with an inability to enrol the required a priori sample size. Kt/V, liters processed per hour and time to next catheter event were not significantly different. There were no serious adverse events attributed to the study medication. CONCLUSIONS: The alteplase push protocol was effective and safe for managing dysfunctional hemodialysis catheters and was more practical than a 2 h dwell.