Low-Intensity vs Moderate-Intensity Anticoagulation for Venovenous Extracorporeal Membrane Oxygenation: The Strategies for Anticoagulation During Venovenous Extracorporeal Membrane Oxygenation Pilot Trial.

Whether lowering the intensity of anticoagulation during venovenous ECMO is safe or effective is unknown.

在静脉-静脉ECMO期间降低抗凝强度是否安全或有效尚不明确。

research_question

Is a large, multicenter randomized trial of low-intensity vs moderate-intensity anticoagulation during venovenous ECMO feasible?

在进行静脉-静脉体外膜氧合（ECMO）期间，低强度与中等强度抗凝治疗的大型多中心随机试验是否可行？

study_design_and_methods

In a multicenter, parallel-group, randomized pilot trial conducted at 3 centers across the United States, we randomly assigned critically ill adults undergoing venovenous ECMO to low-intensity or moderate-intensity anticoagulation.

在美国的3个中心进行的一项多中心、平行组、随机试点试验中，我们随机分配了接受静脉-静脉体外膜氧合（ECMO）治疗的危重病成人患者接受低强度或中等强度抗凝治疗。

Feasibility was assessed by enrollment rate and adherence to the assigned anticoagulation strategy.

可行性通过入组率和对指定抗凝策略的依从性来评估。

The primary efficacy outcome was major bleeding, and the primary safety outcome was thromboembolic events, both assessed between enrollment and 24 hours after decannulation.

主要疗效结果是大出血，主要安全性结果是血栓栓塞事件，两者均在入组至拔管后24小时内评估。

Results

All of the 26 patients enrolled received the assigned intensity of anticoagulation.

所有纳入的26名患者均接受了指定的抗凝强度治疗。

A major bleeding event occurred in 1 of 12 patients (8.3%) in the low-intensity anticoagulation group and in 4 of 14 patients (28.6%) in the moderate-intensity anticoagulation group (absolute risk difference, -20.2 percentage points; 95% CI, -48.6 to 8.1; P = .33).

低强度抗凝组中有1名患者（8.3%）发生了主要出血事件，而中等强度抗凝组中有4名患者（28.6%）发生了主要出血事件（绝对风险差异，-20.2个百分点；95%置信区间，-48.6至8.1；P = .33）。

One patient experienced a thromboembolic event (8.3%) in the low-intensity anticoagulation group compared with none in the moderate-intensity group (difference, 8.3 percentage points; 95% CI, -7.3 to 24.0; P = .46).

在低强度抗凝组中，有1名患者（8.3%）经历了血栓栓塞事件，而在中等强度组中没有患者出现此情况（差异，8.3个百分点；95%置信区间，-7.3至24.0；P = .46）。

No patients died before discharge in the low-intensity anticoagulation group, compared with 2 patients (14.3%) in the moderate-intensity group, both of whom experienced major bleeding events.

在低强度抗凝组中，没有患者在出院前死亡，而在中等强度组中有2名患者（14.3%）死亡，这两位患者都经历了大出血事件。

No patients died before discharge in the low-intensity anticoagulation group, compared with 2 patients (14.3%) in the moderate-intensity group, both of whom experienced major bleeding events.

在低强度抗凝组中，没有患者在出院前死亡，而在中等强度组中有2名患者（14.3%）死亡，这两位患者都经历了大出血事件。

interpretation

Our results indicate that enrollment and separation between groups are feasible in a multicenter randomized trial of low-intensity vs moderate-intensity anticoagulation for critically ill adults receiving venovenous ECMO.

我们的结果表明，在接受静脉-静脉体外膜氧合（ECMO）的重症成人患者中，进行低强度与中等强度抗凝治疗的多中心随机试验的招募和分组是可行的。

A large, multicenter, randomized trial is needed and seems to be feasible.

需要进行一项大规模、多中心、随机试验，并且看起来是可行的。

clinical_trial_registry

ClinicalTrials.gov; No.: NCT04997265; URL: www.

ClinicalTrials.gov; 编号: NCT04997265; 网址: www.

clinicaltrials

gov.

5年总生存率为75%（95%置信区间，65%-85%）。