Italian National Blood Centre, National Institute of Health, Rome, Italy.
Department of Haematology and Transfusion Medicine, "Carlo Poma" Hospital, Mantua, Italy.
Blood Transfus. 2018 May;16(3):235-243. doi: 10.2450/2018.0003-18. Epub 2018 Feb 26.
Thrombelastography (TEG) and rotational thromboelastometry (ROTEM) are viscoelastic haemostatic assays (VHA) which exploit the elastic properties of clotting blood. The aim of this systematic review and meta-analysis was to evaluate the usefulness of these tests in bleeding patients outside the cardiac surgical setting.
We searched the Cochrane Library, MEDLINE, EMBASE and SCOPUS. We also searched clinical trial registries for ongoing and unpublished studies, and checked reference lists to identify additional studies.
We found 4 randomised controlled trials (RCTs) that met our inclusion criteria with a total of 229 participants. The sample size was small (from 28 to 111 patients) and the follow-up periods very heterogenous (from 4 weeks to 3 years). Pooled data from the 3 trials reporting on mortality (199 participants) do not show any effect of the use of TEG on mortality as compared to standard monitoring (based on the average treatment effect from a fixed-effects model): Risk Ratio (RR) 0.71; 95% Confidence Interval (CI): 0.43 to 1.16. Likewise, the use of VHA does not reduce the need for red blood cells (mean difference -0.64; 95% CI: -1.51 to 0.23), platelet concentrates (mean difference -1.12; 95% CI: -3.25 to 1.02), and fresh frozen plasma (mean difference -0.91; 95% CI: -2.02 to 0.19) transfusion. The evidence on mortality and other outcomes was uncertain (very low-certainty evidence, down-graded due to risk of biases, imprecision, and inconsistency).
Overall, the certainty of the evidence provided by the trials was too low for us to be certain of the benefits and harms of viscoelastic haemostatic assay in non-cardiac surgical settings. More, larger, and better-designed RCTs should be carried out in this area.
血栓弹力描记术(TEG)和旋转血栓弹性测定法(ROTEM)是利用凝血血液弹性特性的粘弹性止血测定法(VHA)。本系统评价和荟萃分析的目的是评估这些测试在心脏外科环境之外的出血患者中的有用性。
我们在 Cochrane 图书馆、MEDLINE、EMBASE 和 SCOPUS 中进行了搜索。我们还搜索了临床试验注册处正在进行和未发表的研究,并检查了参考文献列表以确定其他研究。
我们发现了 4 项符合纳入标准的随机对照试验(RCT),共有 229 名参与者。样本量很小(从 28 到 111 例患者),随访期非常异质(从 4 周到 3 年)。3 项报告死亡率的试验(199 名参与者)的汇总数据显示,与标准监测相比,TEG 的使用对死亡率没有任何影响(基于固定效应模型的平均治疗效果):风险比(RR)0.71;95%置信区间(CI):0.43 至 1.16。同样,VHA 的使用并不能减少红细胞(平均差-0.64;95%CI:-1.51 至 0.23)、血小板浓缩物(平均差-1.12;95%CI:-3.25 至 0.12)和新鲜冷冻血浆(平均差-0.91;95%CI:-2.02 至 0.19)的输注需求。关于死亡率和其他结局的证据不确定(非常低确定性证据,因偏倚风险、不精确性和不一致性而下调)。
总体而言,试验提供的证据确定性太低,我们无法确定非心脏手术环境中粘弹性止血测定的益处和危害。应在该领域进行更多、更大和设计更好的 RCT。