Intensive Care Unit, Hospital Universitari Son Espases, Palma de Mallorca.
Department of Neurosurgery, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), Universidad Complutense de Madrid.
Medicine (Baltimore). 2021 Jan 22;100(3):e24206. doi: 10.1097/MD.0000000000024206.
Traumatic brain injury (TBI) constitutes a leading cause of death and disability. Patients with TBI and cerebral contusions developing pericontusional edema are occasionally given dexamethasone on the belief that this edema is similar to that of tumors, in which the beneficial effect of dexamethasone has been demonstrated.
The DEXCON TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo controlled trial to quantify the effects of dexamethasone on the prognosis of TBI patients with brain contusions and pericontusional edema. Adult patients who fulfill the elegibility criteria will be randomized to dexamethasone/placebo in a short and descending course: 4 mg/6 h (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days). The primary outcome is the Glasgow Scale Outcome Extended (GOSE) performed 1 month and 6 months after TBI. Secondary outcomes are: number of episodes of neurological deterioration; symptoms associated with TBI; adverse events; volume of pericontusional edema before and after 12 days of treatment; results of the neuropsychological tests one month and 6 months after TBI. The main analysis will be on an "intention-to-treat" basis. Logistic regression will estimate the effect of dexamethasone/placebo on GOSE at one month and at 6 months, dichotomized in unfavorable outcome (GOSE 1-6) and favorable outcome (GOSE 7-8). Efficacy will also be analyzed using the 'sliding dichotomy'. An interim and safety analysis will be performed including patients recruited during the first year to calculate the conditional power. A study with 600 patients would have 80% power (2 sided alpha = 5%) to detect a 12% absolute increase (from 50% to 62%) in good recovery.
This is a confirmative trial to elucidate the therapeutic efficacy of dexamethasone in a very specific group of TBI patients: patients with brain contusions and pericontusional edema. This trial could become an important milestone for TBI patients as nowadays there is no effective treatment in this type of patients.
eudraCT: 2019-004038-41; Clinical Trials.gov: NCT04303065.
创伤性脑损伤（TBI）是导致死亡和残疾的主要原因。患有 TBI 并伴有脑挫伤形成外伤性脑肿胀的患者有时会给予地塞米松，因为人们认为这种水肿类似于肿瘤，而地塞米松对肿瘤的有益效果已得到证实。
DEXCON TBI 试验是一项多中心、实用、随机、三盲、安慰剂对照试验，旨在量化地塞米松对伴有外伤性脑肿胀和脑挫伤的 TBI 患者预后的影响。符合入选标准的成年患者将被随机分配接受地塞米松/安慰剂治疗，剂量为：4mg/6 小时（2 天）；4mg/8 小时（2 天）；2mg/6 小时（2 天）；2mg/8 小时（2 天）；1mg/8 小时（2 天）；1mg/12 小时（2 天）。主要结局是 TBI 后 1 个月和 6 个月的格拉斯哥结局扩展量表（GOSE）评分。次要结局包括：神经功能恶化发作次数；与 TBI 相关的症状；不良事件；治疗 12 天后外伤性脑肿胀的体积；TBI 后 1 个月和 6 个月的神经心理学测试结果。主要分析将基于“意向治疗”原则进行。逻辑回归将估计地塞米松/安慰剂对 1 个月和 6 个月时 GOSE 的影响，将其分为不良结局（GOSE 1-6）和良好结局（GOSE 7-8）。疗效也将使用“滑动二分法”进行分析。将进行中期和安全性分析，纳入第一年招募的患者，计算条件效力。一项纳入 600 例患者的研究将有 80%的效力（双侧α=5%），以检测良好恢复的绝对增加 12%（从 50%增加到 62%）。
这是一项验证性试验，旨在阐明地塞米松在非常特定的 TBI 患者群体中的治疗效果：脑挫伤和外伤性脑肿胀患者。该试验可能成为 TBI 患者的一个重要里程碑，因为目前这类患者没有有效的治疗方法。
eudraCT：2019-004038-41；ClinicalTrials.gov：NCT04303065。
