院前使用氨甲环酸对创伤性颅内出血患者死亡率和神经结局的影响：来自创伤性脑损伤院前使用氨甲环酸试验的亚组分析。
The effects of prehospital TXA on mortality and neurologic outcomes in patients with traumatic intracranial hemorrhage: A subgroup analysis from the prehospital TXA for TBI trial.
机构信息
From the Department of Surgery (S.R.), University of Chicago, Section of Trauma and Critical Care, Chicago, Illinois; Department of Biostatistics (E.N.M.), University of Washington, Seattle, Washington; Department of Surgery (T.H.G., M. Fleming), Oregon Health & Science University, Section of Trauma and Acute Care Surgery, Portland, Oregon; Department of Emergency Medicine, Oregon Health & Science University (J.J.), Portland, Oregon; Division of Emergency Medicine, Department of Medicine (L.M.), University of Toronto, Toronto, ON, Canada; Department of Surgery (E.B., B.R.), University of Washington, Seattle, Washington; National Heart, Lung, and Blood Institute (G.S.), National Institutes of Health, Atlanta, Georgia; Johns Hopkins University School of Medicine (M.W.), Baltimore, Maryland; Department of Emergency Medicine (J.C.), University of British Columbia, Vancouver, BC, Canada; Bloodworks Northwest (P.K.), Seattle, Washington; Department of Emergency Medicine (J.M.M.), University of Cincinnati, Cincinnati, Ohio; Kingston Health Sciences Center (J.C.), Kingston, ON, Canada; Department of Biostatistics (K.S.), University of Washington, Seattle, Washington; Trauma Surgery (B.T.), Texas Health Presbyterian Hospital, Dallas, Texas; Department of Emergency Medicine (T.A.), Medical College of Wisconsin, Milwaukee, Wisconsin; Department of Surgery (B.C.), McGovern Medical School, University of Texas Health Science Center, San Antonio; Department of Surgery (R.G.), John Peter Smith Health Network, Fort Worth, Texas; Department of Emergency Medicine (A.I.), Department of Internal Medicine (A.I.), University of Texas Southwestern Medical Center, Dallas, Texas; Department of Emergency Medicine (R.J.F.), Regions Hospital St Paul, Saint Paul, Minnesota; Department of Emergency Medicine (M. Ferrara), Baylor University Medical Center, Dallas, Texas; Department of Emergency Medicine (N.R.), John Peter Smith Health Network, Ft. Worth, Texas; Fred Hutchinson Cancer Center (D.K.), Seattle, Washington; British Columbia Emergency Health Services (R.S.), Victoria, BC, Canada; Department of Surgery (D.D.), Regions Hospital, St. Paul, Minnesota; Department of Emergency Medicine (J.T.), University of British Columbia, Vancouver, BC, Canada; Department of Emergency Medicine (A.H.), Hennepin County Medical Center, Minneapolis, Minnesota; Department of Emergency Medicine (M.G.), Medical City Plano, Plano, Texas; Department of Emergency Medicine (J.G.), Baylor University Medical Center; Emergency Medicine (R.S.), Methodist Dallas Medical Center, Dallas, Texas; Department of Surgery (W.I.MK.), University of Chicago, Chicago, Illinois; and Department of Surgery (M.S.), Oregon Health & Science University, Portland, Oregon.
出版信息
J Trauma Acute Care Surg. 2024 Oct 1;97(4):572-580. doi: 10.1097/TA.0000000000004354. Epub 2024 Apr 30.
BACKGROUND
In the prehospital tranexamic acid (TXA) for traumatic brain injury (TBI) trial, TXA administered within 2 hours of injury in the out-of-hospital setting did not reduce mortality in all patients with moderate/severe traumatic brain injury (TBI). We examined the association between TXA dosing arms, neurologic outcome, and mortality in patients with intracranial hemorrhage (ICH) on computed tomography (CT).
METHODS
This was a secondary analysis of the Prehospital Tranexamic Acid for TBI Trial ( ClinicalTrials.gov [NCT01990768]) that randomized adults with moderate/severe TBI (Glasgow Coma Scale score < 13) and systolic blood pressure ≥ 90 mm Hg within 2 hours of injury to a 2-g out-of-hospital TXA bolus followed by an in-hospital saline infusion, a 1-g out-of-hospital TXA bolus/1-g in-hospital TXA infusion, or an out-of-hospital saline bolus/in-hospital saline infusion (placebo). This analysis included the subgroup with ICH on initial CT. Primary outcomes included 28-day mortality, 6-month Glasgow Outcome Scale-Extended (GOSE) ≤ 4, and 6-month Disability Rating Scale (DRS). Outcomes were modeled using linear regression with robust standard errors.
RESULTS
The primary trial included 966 patients. Among 541 participants with ICH, 28-day mortality was lower in the 2-g TXA bolus group (17%) compared with the other two groups (1-g bolus/1-g infusion 26%, placebo 27%). The estimated adjusted difference between the 2-g bolus and placebo groups was -8·5 percentage points (95% confidence interval [CI], -15.9 to -1.0) and between the 2-g bolus and 1-g bolus/1-g infusion groups was -10.2 percentage points (95% CI, -17.6 to -2.9). Disability Rating Scale at 6 months was lower in the 2-g TXA bolus group than the 1-g bolus/1-g infusion (estimated difference - 2.1 [95% CI, -4.2 to -0.02]) and placebo groups (-2.2 [95% CI, -4.3, -0.2]). Six-month GOSE did not differ among groups.
CONCLUSION
A 2-g out-of-hospital TXA bolus in patients with moderate/severe TBI and ICH resulted in lower 28-day mortality and lower 6-month DRS than placebo and standard TXA dosing.
LEVEL OF EVIDENCE
Therapeutic/Care Management; Level II.
背景
在创伤性脑损伤（TBI）的院前氨甲环酸（TXA）试验中，在院外环境中伤后 2 小时内给予 TXA 并不能降低所有中度/重度 TBI 患者的死亡率。我们检查了 CT 显示颅内出血（ICH）的患者中 TXA 剂量臂、神经结局和死亡率之间的关联。
方法
这是对 Prehospital Tranexamic Acid for TBI Trial（ClinicalTrials.gov [NCT01990768]）的二次分析，该试验将中度/重度 TBI（格拉斯哥昏迷量表评分<13）且收缩压≥90mmHg 的成年人随机分配至 2 小时内接受 2g 院外 TXA 推注，然后接受院内生理盐水输注、1g 院外 TXA 推注/1g 院内 TXA 输注或院外生理盐水推注/院内生理盐水输注（安慰剂）。这项分析包括初始 CT 显示 ICH 的亚组。主要结局包括 28 天死亡率、6 个月时格拉斯哥结局量表扩展（GOSE）≤4 和 6 个月时残疾评定量表（DRS）。使用稳健标准误差的线性回归模型来建模。
结果
主要试验纳入了 966 名患者。在 541 名 ICH 患者中，28 天死亡率在 2g TXA 推注组（17%）低于其他两组（1g 推注/1g 输注组 26%，安慰剂组 27%）。2g 推注组与安慰剂组之间的估计调整差异为-8.5 个百分点（95%置信区间 [CI]，-15.9 至-1.0），2g 推注组与 1g 推注/1g 输注组之间的估计差异为-10.2 个百分点（95% CI，-17.6 至-2.9）。2g TXA 推注组 6 个月时的残疾评定量表评分低于 1g 推注/1g 输注组（估计差值-2.1[95% CI，-4.2 至-0.02]）和安慰剂组（-2.2[95% CI，-4.3，-0.2]）。各组之间 6 个月时的 GOSE 没有差异。
结论
在伴有 ICH 的中度/重度 TBI 患者中，院外给予 2g TXA 推注可降低 28 天死亡率和 6 个月时的 DRS，且效果优于安慰剂和标准 TXA 剂量。
证据水平
治疗/护理管理；II 级。
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