基于高敏肌钙蛋白状态的创伤性脑损伤中β受体阻滞剂的使用（BBTBBT）：一项双盲随机对照临床试验的方法学和方案实施。
Beta blocker use in traumatic brain injury based on the high-sensitive troponin status (BBTBBT): methodology and protocol implementation of a double-blind randomized controlled clinical trial.
机构信息
Clinical Research, Trauma & Vascular Surgery Section, Hamad General Hospital (HGH), PO Box 3050, Doha, Qatar.
Clinical Medicine, Weill Cornell Medical College, Doha, Qatar.
出版信息
Trials. 2021 Dec 7;22(1):890. doi: 10.1186/s13063-021-05872-8.
BACKGROUND
Beta-adrenergic receptor blockers (BB) play an important role in the protection of organs that are susceptible for secondary injury due to stress-induced adrenergic surge. However, the use of BB in traumatic brain injury (TBI) patients is not yet the standard of care which necessitates clear scientific evidence to be used. The BBTBBT study aims to determine whether early administration of propranolol based on the high-sensitive troponin T(HsTnT) status will improve the outcome of TBI patients. We hypothesized that early propranolol use is effective in reducing 10- and 30-day mortality in TBI patients. Secondary outcomes will include correlation between serum biomarkers (troponin, epinephrine, cytokines, enolase, S100 calcium binding protein B) and the severity of injury and the impact of BB use on the duration of hospital stay and functional status at a 3-month period.
METHODS
The BBTBBT study is a prospective, randomized, double-blinded, placebo-controlled three-arm trial of BB use in mild-to-severe TBI patients based on the HsTnT status. All enrolled patients will be tested for HsTnT at the first 4 and 6 h post-injury. Patients with positive HsTnT will receive BB if there is no contraindication (group 1). Patients with negative HsTnT will be randomized to receive either propranolol (group 2) or placebo (group 3). The time widow for receiving the study treatment is the first 24 h post-injury.
DISCUSSION
Early BB use may reduce the catecholamine storm and subsequently the cascade of immune and inflammatory changes associated with TBI. HsTnT could be a useful fast diagnostic and prognostic tool in TBI patients. This study will be of great clinical interest to improve survival and functional outcomes of TBI patients.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04508244. Registered on 7 August 2020. Recruitment started on 29 December 2020 and is ongoing.
背景
β肾上腺素能受体阻滞剂（BB）在保护因应激引起的肾上腺素激增而容易受到二次损伤的器官方面发挥着重要作用。然而，BB 在创伤性脑损伤（TBI）患者中的应用尚未成为常规治疗方法，这需要有明确的科学证据来支持。BBTBBT 研究旨在确定基于高敏肌钙蛋白 T（HsTnT）状态的早期普萘洛尔给药是否会改善 TBI 患者的结局。我们假设早期使用普萘洛尔可有效降低 TBI 患者的 10 天和 30 天死亡率。次要结局将包括血清生物标志物（肌钙蛋白、肾上腺素、细胞因子、烯醇化酶、S100 钙结合蛋白 B）与损伤严重程度的相关性，以及 BB 使用对 3 个月时住院时间和功能状态的影响。
方法
BBTBBT 研究是一项基于 HsTnT 状态的前瞻性、随机、双盲、安慰剂对照的 BB 在轻至重度 TBI 患者中的使用的三臂试验。所有入组患者将在伤后第 4 小时和第 6 小时接受 HsTnT 检测。如果没有禁忌症（第 1 组），HsTnT 阳性的患者将接受 BB。HsTnT 阴性的患者将随机接受普萘洛尔（第 2 组）或安慰剂（第 3 组）。接受研究治疗的时间窗口是伤后 24 小时内。
讨论
早期 BB 使用可能会减轻儿茶酚胺风暴，从而减少与 TBI 相关的免疫和炎症变化的级联反应。HsTnT 可能是 TBI 患者有用的快速诊断和预后工具。这项研究将对改善 TBI 患者的生存和功能结局具有重要的临床意义。
试验注册
ClinicalTrials.gov NCT04508244。于 2020 年 8 月 7 日注册。招募于 2020 年 12 月 29 日开始，目前正在进行中。
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