Department of Emergency Medicine, Beaumont Hospital, Royal Oak, Royal Oak, Michigan.
Vascular Access Team, Beaumont Hospital, Royal Oak, Michigan.
JAMA Netw Open. 2021 Oct 1;4(10):e2127836. doi: 10.1001/jamanetworkopen.2021.27836.
Data regarding upper extremity midline catheter (MC)-related thrombosis (CRT) are sparse, with some evidence indicating that MCs have a high rate of CRT.
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.
Inpatients were randomized to receive a 4F antithrombotic MC (MC-AT) or a 4.5F antithrombotic and antimicrobial MC (MC-AT-AM).
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.
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).
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.
ClinicalTrials.gov Identifier: NCT03725293.
有关上肢中线导管（MC）相关血栓形成（CRT）的数据很少，有证据表明 MC 的 CRT 发生率很高。
比较两种具有不同抗血栓形成机制的 MC 对此结果的影响。
设计、设置和参与者：在这项平行的、2 臂随机临床试验中，496 名在三级郊区学术医疗中心住院的成年患者于 2019 年 1 月 1 日至 2020 年 10 月 31 日期间接受 MC，并进行了评估以确定其是否符合入选条件，最终有 212 名患者被随机分配。
住院患者被随机分配接受 4F 抗血栓 MC（MC-AT）或 4.5F 抗血栓和抗菌 MC（MC-AT-AM）。
主要结局是在插入后 30 天内出现症状性中线 CRT，包括深静脉血栓形成或浅表静脉血栓性静脉炎。次要结局包括导管相关性血流感染和导管故障。
共有 191 名患者（平均[SD]年龄，60.2[16.7]岁；114[59.7%]为女性）纳入最终分析：MC-AT 组 94 例，MC-AT-AM 组 97 例。MC-AT 组有 7 例（7.5%）发生症状性中线 CRT，MC-AT-AM 组有 11 例（11.3%）（P=0.46）。MC-AT 组有 5 例（5.3%）发生深静脉血栓形成，MC-AT-AM 组有 5 例（5.2%）（P＞0.99）。MC-AT 组有 1 例发生肺栓塞。两组均无导管相关性血流感染。MC-AT 组有 22 例（23.4%）发生导管早期故障，MC-AT-AM 组有 20 例（20.6%）（P=0.64）。在 Cox 比例风险回归分析中，两组间导管故障的风险无统计学差异（危险比，1.27；95%CI，0.67-2.43；P=0.46）。
两种具有不同抗血栓形成机制的 MC 之间未发现血栓形成存在差异；然而，两组 CRT 的风险都很高。当确定合适的血管通路装置时，医生应充分考虑 MC 相关的安全风险。
ClinicalTrials.gov 标识符：NCT03725293。
