Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol
Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol
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DOI：
10.1136/bmjopen-2020-040550
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发表时间：
2020-01-01
期刊：
影响因子：
2.9
通讯作者：
Bouzat, Pierre
中科院分区：
文献类型：
--
作者：
Payen, Jean-Francois;Richard, Marion;Bouzat, Pierre
颅内高压被认为是严重创伤性脑损伤（TBI）后死亡率和神经功能障碍的独立危险因素。然而，临床研究表明，尽管颅内压（ICP）正常化，但脑缺血/缺氧发作仍很常见。本研究评估了严重TBI后前5天内基于脑组织氧合压（PbtO（2））和ICP监测的指导治疗策略对神经学结局的影响。方法：对300例严重脑外伤患者进行多中心、开放、随机、对照、优效性试验。脑内监测必须在创伤后16小时内到位。患者被随机分配到ICP组或ICP + PbtO（2）组。ICP组根据国际指南进行管理，以维持ICP = 20 mm Hg以及ICP的常规优化。主要结局指标是使用扩展的格拉斯哥结局量表评估的6个月时的神经系统状态。次要结局指标包括生活质量评估、死亡率、治疗强度和前5天内严重事件的发生率。将根据意向治疗原则和数据库冻结前制定的完整统计分析计划进行分析。伦理和传播本研究已获得苏德-埃斯特V机构审查委员会（14-CHUG-48）和国家药品和健康产品安全局（Agence Nationale de Securite du Medicament et des produits de sante）（141 435 B-31）的批准。研究结果将在科学会议上公布，并发表在同行评审的出版物上。本研究于2016年4月28日在ClinTrials NCT 02754063注册（预结果）。
Introduction Intracranial hypertension is considered as an independent risk factor of mortality and neurological disabilities after severe traumatic brain injury (TBI). However, clinical studies have demonstrated that episodes of brain ischaemia/hypoxia are common despite normalisation of intracranial pressure (ICP). This study assesses the impact on neurological outcome of guiding therapeutic strategies based on the monitoring of both brain tissue oxygenation pressure (PbtO(2)) and ICP during the first 5 days following severe TBI. Methods and analysis Multicentre, open-labelled, randomised controlled superiority trial with two parallel groups in 300 patients with severe TBI. Intracerebral monitoring must be in place within the first 16 hours post-trauma. Patients are randomly assigned to the ICP group or to the ICP + PbtO(2)group. The ICP group is managed according to the international guidelines to maintain ICP = 20 mm Hg in addition to the conventional optimisation of ICP. The primary outcome measure is the neurological status at 6 months as assessed using the extended Glasgow Outcome Scale. Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days. Analysis will be performed according to the intention-to-treat principle and full statistical analysis plan developed prior to database freeze. Ethics and dissemination This study has been approved by the Institutional Review Board of Sud-Est V (14-CHUG-48) and from the National Agency for Medicines and Health Products Safety (Agence Nationale de Securite du Medicament et des produits de sante) (141 435B-31). Results will be presented at scientific meetings and published in peer-reviewed publications. The study was registered with ClinTrials NCT02754063 on 28 April 2016 (pre-results).