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

ABSTRACT

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. Trial Registration ClinicalTrials.gov Identifier NCT03725293.