心脏手术中凝血酶生成的滴定与常规抗凝管理：一项随机对照试验。

Titrated versus conventional anticoagulation management for thrombin generation in cardiac surgery: a randomized controlled trial.

机构信息

Perfusion Services, University Health Network, Toronto, ON, Canada.

Department of Anesthesia and Pain Management, Sinai Health System, Women's College Hospital, University Health Network, Toronto, ON, Canada.

出版信息

Can J Anaesth. 2022 Sep;69(9):1117-1128. doi: 10.1007/s12630-022-02278-1. Epub 2022 Jul 8.

DOI:10.1007/s12630-022-02278-1

PMID:35799088

Abstract

PURPOSE

Optimal heparin titration during cardiopulmonary bypass (CPB) may reduce coagulation system activation and preserve hemostatic function post-CPB. Our objective was to assess if the Heparin Management System (HMS) Plus improves heparin titration, thereby leading to higher thrombin generation post-CPB compared with activated clotting time (ACT)-guided management.

METHODS

We conducted a randomized controlled trial of 100 patients undergoing cardiac surgery with CPB at a single center. A total of 50 patients were randomized to conventional ACT-guided management, and 50 to the HMS Plus system. The primary outcome was change in thrombin generation post-CPB compared with baseline, as assessed by calibrated automated thrombography. Secondary outcomes included intraoperative blood loss, chest drain output up to 72 hr, and transfusions. In an exploratory analysis, we compared the quintile of patients with the highest average heparin concentration on CPB (≥ 4.0 mg⋅kg) with the rest of the cohort.

RESULTS

A total of 100 patients were included in an intent-to-treat analysis. We observed no difference in post-CPB thrombin generation or secondary outcomes. However, patients in the HMS Plus group had higher average heparin concentrations while on CPB than patients in the conventional management group did (mean difference, -0.21; 95% confidence interval, -0.42 to -0.01). The quintile of patients with the highest average heparin concentration (4.0 mg⋅kg) had higher thrombin generation post-CPB than the rest of the cohort did.

CONCLUSIONS

The HMS Plus system did not show significant benefits in thrombin generation, bleeding outcomes, or transfusion in patients undergoing cardiac surgery with CPB. Higher average heparin concentrations on CPB were associated with higher post-CPB thrombin generation.

STUDY REGISTRATION

www.

CLINICALTRIALS

gov (NCT03347201); first submitted 12 October 2017.

摘要

目的

体外循环（CPB）期间最佳肝素滴定可能会减少凝血系统的激活并维持 CPB 后的止血功能。我们的目的是评估肝素管理系统（HMS）加是否可以改善肝素滴定，从而导致 CPB 后比激活凝血时间（ACT）指导管理的血栓生成更高。

方法

我们在一个中心进行了一项随机对照试验，共纳入 100 例接受 CPB 心脏手术的患者。将 50 例患者随机分为常规 ACT 指导管理组，50 例患者分为 HMS 加系统组。主要结局是通过校准自动血栓形成评估 CPB 后与基线相比血栓生成的变化。次要结局包括术中失血量、72 小时内胸腔引流量和输血。在一项探索性分析中，我们比较了 CPB 期间肝素平均浓度最高（≥4.0mg/kg）的患者的五分位数与其余患者的情况。

结果

共有 100 例患者进行了意向治疗分析。我们没有观察到 CPB 后血栓生成或次要结局的差异。然而，HMS 加组患者在 CPB 期间的平均肝素浓度高于常规管理组（平均差异，-0.21；95%置信区间，-0.42 至-0.01）。肝素平均浓度最高（4.0mg/kg）的五分位数患者的 CPB 后血栓生成高于其余患者。