心脏手术中的即时止血检测：一项阶梯式楔形集群随机对照试验。

Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial.

机构信息

From Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, University of Toronto, Canada (K.K.); Department of Laboratory Medicine and Pathobiology, Sunnybrook Health Sciences Centre, University of Toronto, Canada (J.C.); Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, University of Toronto, and Li Ka Shing Knowledge Institute of St. Michael's Hospital, Canada (D.N.W.); Division of Cardiac Surgery, Department of Surgery, Toronto General Hospital, University Health Network, University of Toronto, Canada (V.R.); Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Canada (M.C.); Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, Canada (H.P.G.); Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Canada (R.P.); Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and Interdepartmental Division of Critical Care, University of Toronto, Canada (D.C.S.); and the Peter Munk Cardiac Centre, University Health Network, Toronto, Canada (K.K., D.N.W., V.R.).

出版信息

Circulation. 2016 Oct 18;134(16):1152-1162. doi: 10.1161/CIRCULATIONAHA.116.023956. Epub 2016 Sep 21.

DOI:10.1161/CIRCULATIONAHA.116.023956

PMID:27654344

Abstract

BACKGROUND

Cardiac surgery is frequently complicated by coagulopathic bleeding that is difficult to optimally manage using standard hemostatic testing. We hypothesized that point-of-care hemostatic testing within the context of an integrated transfusion algorithm would improve the management of coagulopathy in cardiac surgery and thereby reduce blood transfusions.

METHODS

We conducted a pragmatic multicenter stepped-wedge cluster randomized controlled trial of a point-of-care-based transfusion algorithm in consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at 12 hospitals from October 6, 2014, to May 1, 2015. Following a 1-month data collection at all participating hospitals, a transfusion algorithm incorporating point-of-care hemostatic testing was sequentially implemented at 2 hospitals at a time in 1-month intervals, with the implementation order randomly assigned. No other aspects of care were modified. The primary outcome was red blood cell transfusion from surgery to postoperative day 7. Other outcomes included transfusion of other blood products, major bleeding, and major complications. The analysis adjusted for secular time trends, within-hospital clustering, and patient-level risk factors. All outcomes and analyses were prespecified before study initiation.

RESULTS

Among the 7402 patients studied, 3555 underwent surgery during the control phase and 3847 during the intervention phase. Overall, 3329 (45.0%) received red blood cells, 1863 (25.2%) received platelets, 1645 (22.2%) received plasma, and 394 (5.3%) received cryoprecipitate. Major bleeding occurred in 1773 (24.1%) patients, and major complications occurred in 740 (10.2%) patients. The trial intervention reduced rates of red blood cell transfusion (adjusted relative risk, 0.91; 95% confidence interval, 0.85-0.98; P=0.02; number needed to treat, 24.7), platelet transfusion (relative risk, 0.77; 95% confidence interval, 0.68-0.87; P<0.001; number needed to treat, 16.7), and major bleeding (relative risk, 0.83; 95% confidence interval, 0.72-0.94; P=0.004; number needed to treat, 22.6), but had no effect on other blood product transfusions or major complications.

CONCLUSIONS

Implementation of point-of-care hemostatic testing within the context of an integrated transfusion algorithm reduces red blood cell transfusions, platelet transfusions, and major bleeding following cardiac surgery. Our findings support the broader adoption of point-of-care hemostatic testing into clinical practice.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT02200419.

摘要

背景

心脏手术常伴有凝血功能障碍性出血，使用标准止血检测方法难以进行最佳管理。我们假设在综合输血算法中使用即时止血检测可改善心脏手术中凝血功能障碍的管理，从而减少输血。

方法

我们开展了一项实用的多中心阶梯式楔形群随机对照试验，在 12 家医院的心肺旁路心脏手术连续患者中，于 2014 年 10 月 6 日至 2015 年 5 月 1 日采用即时止血检测的基于即时检测的输血算法。在所有参与医院进行了 1 个月的数据收集后，以 1 个月为间隔，分两次在 2 家医院依次实施纳入即时检测的输血算法，实施顺序随机分配。不改变其他治疗方法。主要结局是从手术到术后第 7 天的红细胞输血。其他结局包括其他血液制品的输血、大出血和主要并发症。分析调整了时间趋势、院内聚类和患者水平的危险因素。所有结局和分析在研究开始前均已预先设定。

结果

在 7402 例患者中，3555 例在对照组期间进行了手术，3847 例在干预组期间进行了手术。总体而言，3329 例（45.0%）接受了红细胞输血，1863 例（25.2%）接受了血小板输血，1645 例（22.2%）接受了血浆输血，394 例（5.3%）接受了冷沉淀输血。1773 例（24.1%）患者发生大出血，740 例（10.2%）患者发生主要并发症。试验干预降低了红细胞输血率（调整后的相对风险，0.91；95%置信区间，0.85-0.98；P=0.02；需要治疗的人数，24.7）、血小板输血率（相对风险，0.77；95%置信区间，0.68-0.87；P<0.001；需要治疗的人数，16.7）和大出血发生率（相对风险，0.83；95%置信区间，0.72-0.94；P=0.004；需要治疗的人数，22.6），但对其他血液制品输血或主要并发症无影响。