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氨甲环酸在入院时给药不会减少髋关节囊外骨折的输血率或出血量:一项双盲随机临床试验。

Tranexamic Acid Administered at Time of Hospital Admission Does Not Decrease Transfusion Rates or Blood Loss for Extracapsular Hip Fractures: A Double-Blinded Randomized Clinical Trial.

机构信息

Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN; and.

Department of Emergency Medicine, Mayo Clinic, Rochester, MN.

出版信息

J Orthop Trauma. 2024 Oct 1;38(10):515-520. doi: 10.1097/BOT.0000000000002870.

Abstract

OBJECTIVES

To evaluate tranexamic acid (TXA) when administered immediately on hospital presentation in patients with extracapsular peritrochanteric hip fractures to determine its effect on (1) transfusion rates, (2) estimated blood loss, and (3) complications.

DESIGN

Prospective, double-blinded, randomized clinical trial.

SETTING

Single-center, Level 1 trauma center.

PATIENT SELECTION CRITERIA

All patients with isolated OTA/AO 31-A fracture patterns from 2018 to 2022 were eligible for inclusion. Study drug was administered in the emergency department at the time of presentation-1-g bolus over 10 minutes followed by a 1-g infusion over 8 hours.

OUTCOME MEASURES AND COMPARISONS

The primary outcome was the rate of red blood cell transfusion hospital days 1-4. Secondary outcomes included estimated blood loss and complications including venous thromboembolic events, stroke, myocardial infarction, all-cause 90-day readmissions, and all-cause mortality.

RESULTS

One hundred twenty-eight patients were included-64 patients were randomized to intravenous TXA and 64 patients to intravenous normal saline (ie, placebo). There was no difference in the rate of red blood cell transfusion between treatment arms between hospital days 1-4 (27% in the TXA arm vs. 31% in the placebo arm, P = 0.65). Patients randomized to placebo who required transfusion received a mean of 2.30 units compared with 1.94 units in the TXA cohort (P = 0.55). There was no difference in the estimated blood loss between hospital days 1-4. There was no difference in the incidence of postoperative complications including venous thromboembolic events, stroke, myocardial infarction, 90-day readmission, or death.

CONCLUSIONS

The results of this study do not support the use of preoperative TXA for reducing blood loss for geriatric patients with extracapsular hip fractures.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

摘要

目的

评估氨甲环酸(TXA)在出现于医院的囊外股骨转子间骨折患者中的即时给药效果,以确定其对(1)输血率、(2)估计失血量和(3)并发症的影响。

设计

前瞻性、双盲、随机临床试验。

设置

单中心、1 级创伤中心。

患者入选标准

所有 2018 年至 2022 年符合 OTA/AO 31-A 骨折模式的孤立性股骨转子间骨折患者均符合纳入标准。在急诊科就诊时给予研究药物-1g 负荷剂量静脉推注 10 分钟,然后静脉滴注 1g 持续 8 小时。

结局指标和比较

主要结局是第 1-4 住院天的红细胞输血率。次要结局包括估计失血量和并发症,包括静脉血栓栓塞事件、中风、心肌梗死、90 天全因再入院和全因死亡率。

结果

共纳入 128 例患者-64 例患者随机分为静脉 TXA 组,64 例患者随机分为静脉生理盐水(即安慰剂)组。第 1-4 住院天,治疗组之间的红细胞输血率无差异(TXA 组为 27%,安慰剂组为 31%,P=0.65)。需要输血的安慰剂组患者平均输注 2.30 单位,而 TXA 组为 1.94 单位(P=0.55)。第 1-4 住院天的估计失血量无差异。术后并发症发生率,包括静脉血栓栓塞事件、中风、心肌梗死、90 天再入院或死亡,无差异。

结论

本研究结果不支持术前使用 TXA 减少囊外髋部骨折老年患者的失血。

证据水平

治疗性 I 级。请参阅作者说明,以获取完整的证据水平描述。

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