Missingness matters: a secondary analysis of thromboelastography measurements from a recent prehospital randomized tranexamic acid clinical trial.
Missingness matters: a secondary analysis of thromboelastography measurements from a recent prehospital randomized tranexamic acid clinical trial.
复制标题
缺失很重要：对最近一项院前随机氨甲环酸临床试验的血栓弹力图测量结果进行二次分析。
DOI：
10.1136/tsaco-2023-001346
复制
发表时间：
2024
影响因子：
2
通讯作者：
Sperry,JasonL
中科院分区：
文献类型：
--
作者：
Donohue,JackK;Iyanna,Nidhi;Lorence,JohnM;Brown,JoshuaB;Guyette,FrancesX;Eastridge,BrianJ;Nirula,Raminder;Vercruysse,GaryA;O'Keeffe,Terence;Joseph,Bellal;Neal,MatthewD;Sperry,JasonL
研究背景氨甲环酸（TXA）被认为可以减轻创伤后患者的凝血功能障碍。尽管先前的院前临床试验证明了TXA的生存益处，但没有一项试验证明了血栓弹力图（TEG）参数的相关变化。我们试图分析，如果缺少TEG的数据有助于这种缺乏的findings.MethodsWe进行了二次分析的氨甲环酸在空中医疗和地面院前运输试验的研究。我们比较了接受TEG的患者（YES-TEG）和无法采样的患者（NO-TEG），以分析研究TEG差异的亚组。在NO-TEG相对于YES-TEG队列不成比例存在的亚组内评估TXA干预组间的TEG参数差异。控制潜在混杂因素的广义线性模型应用于单变量分析中p<0.10的结果。（100（78，140）vs 125（88，147），p<0.01），较低的院前奶牛昏迷评分（14（3，15）vs 15（12，15），p<0.01），院前插管率更高（39.4%vs 24.4%，p<0.01），30天死亡率更高（36.4%vs 6.8%，p<0.01）。NO-TEG患者的国际标准化比值高于YES-TEG亚组（1.2（1.1，1.5）vs 1.1（1.0，1.2），p=0.04）。在严重院前休克队列（SBP<70）中，多变量分析显示，TXA与30分钟时血栓溶解显著减少相关（β=−27.6，95%CI（−51.3至-3.9），p=0.02）。结论缺失数据，由于对某些严重受伤患者进行采样的后勤挑战，可能与主要分析中TXA给药时TEG参数变化缺乏相关。先前对TXA在严重院前休克患者中的生存益处的证明与当前的研究结果相结合，支持TXA至少部分通过改善血栓完整性发挥作用的观点。证据等级II级。
BackgroundTranexamic acid (TXA) has been hypothesized to mitigate coagulopathy in patients after traumatic injury. Despite previous prehospital clinical trials demonstrating a TXA survival benefit, none have demonstrated correlated changes in thromboelastography (TEG) parameters. We sought to analyze if missing TEG data contributed to this paucity of findings.MethodsWe performed a secondary analysis of the Study of Tranexamic Acid During Air Medical and Ground Prehospital Transport Trial. We compared patients that received TEG (YES-TEG) and patients unable to be sampled (NO-TEG) to analyze subgroups in which to investigate TEG differences. TEG parameter differences across TXA intervention arms were assessed within subgroups disproportionately present in the NO-TEG relative to the YES-TEG cohort. Generalized linear models controlling for potential confounders were applied to findings with p<0.10 on univariate analysis.ResultsNO-TEG patients had lower prehospital systolic blood pressure (SBP) (100 (78, 140) vs 125 (88, 147), p<0.01), lower prehospital Glascow Coma Score (14 (3, 15) vs 15 (12, 15), p<0.01), greater rates of prehospital intubation (39.4% vs 24.4%, p<0.01) and greater mortality at 30 days (36.4% vs 6.8%, p<0.01). NO-TEG patients had a greater international normalized ratio relative to the YES-TEG subgroup (1.2 (1.1, 1.5) vs 1.1 (1.0, 1.2), p=0.04). Within a severe prehospital shock cohort (SBP<70), TXA was associated with a significant decrease in clot lysis at 30 min on multivariate analysis (β=−27.6, 95% CI (−51.3 to –3.9), p=0.02).ConclusionsMissing data, due to the logistical challenges of sampling certain severely injured patients, may be associated with a lack of TEG parameter changes on TXA administration in the primary analysis. Previous demonstration of TXA’s survival benefit in patients with severe prehospital shock in tandem with the current findings supports the notion that TXA acts at least partially by improving clot integrity.Level of evidenceLevel II.