Comparison of 2 Midline Catheter Devices With Differing Antithrombogenic Mechanisms for Catheter-Related Thrombosis A Randomized Clinical Trial

Importance Data regarding upper extremity midline catheter (MC)-related thrombosis (CRT) are sparse, with some evidence indicating that MCs have a high rate of CRT. Objective To compare 2 MCs with differing antithrombogenic mechanisms for this outcome. Design, Setting, and Participants In this parallel, 2-arm randomized clinical trial, 496 adult patients hospitalized at a tertiary care suburban academic medical center who received an MC were assessed for eligibility between January 1, 2019, and October 31, 2020, and 212 were randomized. Interventions Inpatients were randomized to receive a 4F antithrombotic MC (MC-AT) or a 4.5F antithrombotic and antimicrobial MC (MC-AT-AM). Main Outcomes and Measures The primary outcome was symptomatic midline CRT inclusive of deep vein thrombosis or superficial venous thrombophlebitis within 30 days after insertion. Secondary outcomes included catheter-associated bloodstream infection and catheter failure. Results A total of 191 patients (mean [SD] age, 60.2 [16.7] years; 114 [59.7%] female) were included in the final analysis: 94 patients in the MC-AT group and 97 in the MC-AT-AM group. Symptomatic midline CRT occurred in 7 patients (7.5%) in the MC-AT group and 11 (11.3%) in the MC-AT-AM group (P = .46). Deep vein thrombosis occurred in 5 patients (5.3%) in the MC-AT group and 5 patients (5.2%) in the MC-AT-AM group (P > .99). Pulmonary embolism occurred in 1 patient in the MC-AT group. No catheter-associated bloodstream infection occurred in either group. Premature catheter failure occurred in 22 patients (23.4%) in the MC-AT group and 20 (20.6%) in the MC-AT-AM group (P = .64). In Cox proportional hazards regression analysis, no statistically significant difference was found between groups for the risk of catheter failure (hazard ratio, 1.27; 95% CI, 0.67-2.43; P = .46). Conclusions and Relevance No difference was found in thrombosis in MCs with 2 distinct antithrombogenic mechanisms; however, the risk of CRT in both groups was high. Practitioners should strongly consider the safety risks associated with MCs when determining the appropriate vascular access device. Question Is there a difference in midline catheter-related thrombosis (deep vein thrombosis or superficial vein thrombophlebitis) using devices with 2 distinct antithrombogenic mechanisms? Findings In this randomized clinical trial of 191 adults randomized to receive an antithrombotic catheter or an antithrombotic, antimicrobial catheter, no difference was found in catheter-related thrombosis between the 2 trial devices (7.5% and 11.3%). Meaning The catheter-related thrombosis rate was high in both catheters with no advantage of either antithrombogenic mechanism. This randomized clinical trial evaluates whether thrombosis risk can be mitigated with the use of an alternative midline catheter with a chlorhexidine gluconate coating that reduces fibrin sheath development.