A prototype line clamp for venous access bleeding in hemodialysis: A prospective cohort study.

INTRODUCTION: Venous needle dislodgement (or venous port disconnection) during hemodialysis (HD) may lead to catastrophic blood loss, particularly during unsupervised home HD. A prototype venous line clamp was developed for use in conjunction with the Redsense blood loss sensor. We hypothesize that this prototype device will provide additional safety to dialysis without excessive burden. METHODS: This was a single-center, prospective cohort study. Participants kept a log of bleeding, troubleshooting and clamp deployment events, and completed questionnaires before device first use and after device final use. The primary outcome was appropriate device function, evaluated by review of bleeding and clamp deployment events. The secondary outcomes were patient/nursing staff expectations and experience of the device. FINDINGS: Fourteen patients used the device during a combined total of 214 HD treatments. Five participants (36%) had experienced a bleeding or disconnection event prior to study recruitment. All vascular access types were represented. The device was tested during incenter HD (n = 7 patients) and home HD (n = 7 patients). There were eight clamp deployment events, three of which were in the setting of minor bleeding at the venous access site. No other bleeding events were reported. The main troubleshooting issues were related to cumbersome device connections. Participants perceived additional safety with the device (median score 4.25 out of 5; range 1-5). However, the amount of additional work created was variable, and large in some cases (median score 2 out of 5; range 0-4.5). There was no association between HD vintage and device burden (P = 0.55). DISCUSSION: This "proof of concept" study confirmed that a clamp on the venous line, operating in conjunction with a venous access blood detector, is feasible regardless of HD location or vascular access type. The device improved patient safety perception during HD but was burdensome. Design modifications could improve future device iterations.