Importance Trials often assess primary outcomes of traumatic brain injury at 6 months. Longer-term data are needed to assess outcomes for patients receiving surgical vs medical treatment for traumatic intracranial hypertension. Objective To evaluate 24-month outcomes for patients with traumatic intracranial hypertension treated with decompressive craniectomy or standard medical care. Design, Setting, and Participants Prespecified secondary analysis of the Randomized Evaluation of Surgery With Craniectomy for Uncontrollable Elevation of Intracranial Pressure (RESCUEicp) randomized clinical trial data was performed for patients with traumatic intracranial hypertension (>25 mm Hg) from 52 centers in 20 countries. Enrollment occurred between January 2004 and March 2014. Data were analyzed between 2018 and 2021. Eligibility criteria were age 10 to 65 years, traumatic brain injury (confirmed via computed tomography), intracranial pressure monitoring, and sustained and refractory elevated intracranial pressure for 1 to 12 hours despite pressure-controlling measures. Exclusion criteria were bilateral fixed and dilated pupils, bleeding diathesis, or unsurvivable injury. Interventions Patients were randomly assigned 1:1 to receive a decompressive craniectomy with standard care (surgical group) or to ongoing medical treatment with the option to add barbiturate infusion (medical group). Main Outcomes and Measures The primary outcome was measured with the 8-point Extended Glasgow Outcome Scale (1 indicates death and 8 denotes upper good recovery), and the 6- to 24-month outcome trajectory was examined. Results This study enrolled 408 patients: 206 in the surgical group and 202 in the medical group. The mean (SD) age was 32.3 (13.2) and 34.8 (13.7) years, respectively, and the study population was predominantly male (165 [81.7%] and 156 [80.0%], respectively). At 24 months, patients in the surgical group had reduced mortality (61 [33.5%] vs 94 [54.0%]; absolute difference, -20.5 [95% CI, -30.8 to -10.2]) and higher rates of vegetative state (absolute difference, 4.3 [95% CI, 0.0 to 8.6]), lower or upper moderate disability (4.7 [-0.9 to 10.3] vs 2.8 [-4.2 to 9.8]), and lower or upper severe disability (2.2 [-5.4 to 9.8] vs 6.5 [1.8 to 11.2]; χ27 = 24.20, P = .001). For every 100 individuals treated surgically, 21 additional patients survived at 24 months; 4 were in a vegetative state, 2 had lower and 7 had upper severe disability, and 5 had lower and 3 had upper moderate disability, respectively. Rates of lower and upper good recovery were similar for the surgical and medical groups (20 [11.0%] vs 19 [10.9%]), and significant differences in net improvement (≥1 grade) were observed between 6 and 24 months (55 [30.0%] vs 25 [14.0%]; χ22 = 13.27, P = .001). Conclusions and Relevance At 24 months, patients with surgically treated posttraumatic refractory intracranial hypertension had a sustained reduction in mortality and higher rates of vegetative state, severe disability, and moderate disability. Patients in the surgical group were more likely to improve over time vs patients in the medical group. Trial Registration ISRCTN Identifier: 66202560.

中文翻译：

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外伤性颅内压增高患者在 24 个月时接受去骨瓣减压术与标准医疗治疗的结果评估：RESCUEicp 随机临床试验的二次分析。

重要性试验通常评估 6 个月时创伤性脑损伤的主要结果。需要更长期的数据来评估接受手术治疗与药物治疗治疗创伤性颅内高压的患者的结局。目的 评估接受去骨瓣减压术或标准医疗护理的外伤性颅内高压患者 24 个月的结果。设计、设置和参与者 对 20 个国家/地区 52 个中心的外伤性颅内高压 (>25 mm Hg) 患者进行随机临床试验数据的随机评估随机评估颅内压升高 (RESCUEicp) 的设计、设置和参与者. 登记发生在 2004 年 1 月至 2014 年 3 月之间。数据分析于 2018 年至 2021 年之间。入选标准为 10 至 65 岁、创伤性脑损伤（通过计算机断层扫描确认）、颅内压监测以及尽管采取了压力控制措施但颅内压持续和顽固性升高 1 至 12 小时。排除标准是双侧瞳孔固定和散大、出血素质或无法存活的损伤。干预 患者按 1:1 的比例随机分配，接受标准护理的去骨瓣减压术（手术组）或接受持续药物治疗并可选择加用巴比妥类药物输注（药物组）。主要结果和测量 主要结果使用 8 分扩展格拉斯哥结果量表（1 表示死亡，8 表示恢复良好）进行测量，并检查 6 至 24 个月的结果轨迹。结果 本研究纳入了 408 名患者：手术组 206 人，医疗组 202 人。平均 (SD) 年龄分别为 32.3 (13.2) 和 34.8 (13.7) 岁，研究人群主要为男性（分别为 165 [81.7%] 和 156 [80.0%]）。在 24 个月时，手术组患者的死亡率降低（61 [33.5%] 对 94 [54.0%]；绝对差为 -20.5 [95% CI，-30.8 至 -10.2]）并且植物人状态发生率更高（绝对差异，4.3 [95% CI，0.0 至 8.6]），较低或较高的中度残疾（4.7 [-0.9 至 10.3] 对比 2.8 [-4.2 至 9.8]），以及较低或较高的严重残疾（2.2 [-5.4 至 9.8] ] 对比 6.5 [1.8 至 11.2]；χ27 = 24.20，P = .001）。每 100 名接受手术治疗的患者，就有 21 名患者在 24 个月时存活；植物人4人，下重度残疾2人，上重度残疾7人，中度残疾5人，上中度残疾3人，分别。手术组和药物组的下部和上部良好恢复率相似（20 [11.0%] vs 19 [10.9%]），并且在 6 个月和 24 个月之间观察到净改善（≥1 级）的显着差异（55 [ 30.0%] 对比 25 [14.0%]；χ22 = 13.27，P = .001）。结论和相关性 在 24 个月时，接受手术治疗的创伤后难治性颅内高压患者的死亡率持续降低，植物人状态、严重残疾和中度残疾的发生率更高。与药物组患者相比，手术组患者更有可能随着时间的推移而改善。试用注册 ISRCTN 标识符：66202560。在 6 个月和 24 个月之间观察到净改善（≥1 级）的显着差异（55 [30.0%] 对 25 [14.0%]；χ22 = 13.27，P = .001）。结论和相关性 在 24 个月时，接受手术治疗的创伤后难治性颅内高压患者的死亡率持续降低，植物人状态、严重残疾和中度残疾的发生率更高。与药物组患者相比，手术组患者更有可能随着时间的推移而改善。试用注册 ISRCTN 标识符：66202560。在 6 个月和 24 个月之间观察到净改善（≥1 级）的显着差异（55 [30.0%] 对 25 [14.0%]；χ22 = 13.27，P = .001）。结论和相关性 在 24 个月时，接受手术治疗的创伤后难治性颅内高压患者的死亡率持续降低，植物人状态、严重残疾和中度残疾的发生率更高。与药物组患者相比，手术组患者更有可能随着时间的推移而改善。试用注册 ISRCTN 标识符：66202560。和中度残疾。与药物组患者相比，手术组患者更有可能随着时间的推移而改善。试用注册 ISRCTN 标识符：66202560。和中度残疾。与药物组患者相比，手术组患者更有可能随着时间的推移而改善。试用注册 ISRCTN 标识符：66202560。