Capacity Building for Decompressive Craniotomy in Colombia

描述(由申请人提供)：在中低收入国家(LMIC)，遭受包括创伤性脑损伤(TBI)在内的严重创伤的患者死亡的概率是高收入国家(HIC)患者的两到六倍。这一差距与技术资源水平较低有关，包括监测颅内压。重型颅脑损伤(STBI)患者死亡和残疾的主要危险因素是脑肿胀引起的颅内压升高。去颅骨减压术(DC)是一种神经外科手术，在这种手术中，颅骨的一大部分被移除，以便为肿胀的大脑提供更多的空间，而不会进一步增加颅内压。《严重创伤性脑损伤处理指南》中的循证治疗选择依赖于颅内压监测，以了解何时以及如何进行干预。一个尚未得到回答的重要问题是，在哪些患者中，是否以及哪些患者应该及早(伤后6-12小时内)或推迟(伤后12-48小时，重症监护病房[ICU]医疗失败后)进行DC。目前，正在进行几个随机对照试验(RCT)来回答这个问题，但不幸的是，只在有颅内压监测的患者中进行。然而，大多数发展中国家无法使用比较方案监测仪。因此，有必要在没有ICP监测仪的环境中对脑损伤的临床评估采取标准化的方法，确定有效的、低成本的、以方案为导向的治疗干预措施，以及建立开展脑损伤研究的能力。哥伦比亚是一个脑外伤发病率非常高的国家，其卫生基础设施已做好准备，可促进神经创伤的能力建设 临床研究。我们建议在哥伦比亚通过在三个创伤中心进行一项试点研究来发展正在进行的神经创伤研究的能力，在该研究中，我们将开发并引入一种治疗sTBI患者的算法。该算法将包括以下内容的核对表 早期DC患者的选择以及他们术中和术后护理的方案。我们会 比较引入该算法前后sTBI患者的治疗结果，该算法将提供初步数据，以支持在没有颅内压监测仪的临床环境下进行DC的随机对照试验。 公共卫生相关性：该项目的目标是建设能力，以便为在哥伦比亚实施神经创伤临床研究建立坚实的基础设施。在研究结束时，我们将有初步的数据来支持关于减压开颅手术的随机对照试验，该试验适用于大多数LMIC典型的技术匮乏的环境。这一努力将能够产生与发展中国家TBI的实际环境和健康需求相关的具体公共卫生问题的高质量数据

DESCRIPTION (provided by applicant): In Low-to-Middle Income Countries (LMICs), the probability of death for patients sustaining a severe trauma, including traumatic brain injury (TBI), is two to six times greater than for patients in High Income Countries (HICs). This disparity is associated with lower levels of technical resources, including monitoring of intracranial pressure (ICP). A main risk factor for death and disability in severe TBI (sTBI) patients is increased ICP due to brain swelling. Decompressive craniectomy (DC) is a neurosurgical procedure in which a large portion of the skull is removed to allow more space for a swelling brain to expand without further increasing ICP. The evidence- based treatment options in The Guidelines for the Management of Severe Traumatic Brain Injury rely on ICP monitoring to know when and how to intervene. An important question, yet unanswered, is whether, and in which patients, DC should be performed early (within 6-12 hours post-injury), or delayed (12 to 48 hours post-injury, and after Intensive Care Unit [ICU] medical treatment fails). Currently, several randomized controlled trials (RCTs) are being conducted to answer that question, but unfortunately, only in patients who have ICP monitoring. However, most of the developing world does not have access to ICP monitors. Thus, there is a need for standardized approaches to clinical assessment of TBI in environments without ICP monitors, and for the identification of effective, low-cost, protocol-driven interventions for treatment as well as to create of capacity to conduct research about TBI. Colombia, a country with a very high incidence of TBI, has a health infrastructure ready to facilitate capacity building for neurotrauma clinical research. We propose to develop capacity for ongoing neurotrauma research in Colombia, by conducting a pilot study in three trauma centers in which we will develop and introduce an algorithm for the care of sTBI patients. The algorithm will consist of a checklist for selection of patients for early DC and a protocol for their inter- and post-operative care. We will compare outcomes for sTBI patients treated before and after the introduction of the algorithm, which will provide preliminary data to support an RCT about DC in clinical settings without ICP monitors. PUBLIC HEALTH RELEVANCE: The objective of this project is to build capacity in order to create a solid infrastructure for the implementation of Clinical Research in Neuro-trauma in Colombia. At the end of the study we will have preliminary data to support a RCT about decompressive Craniotomy applicable to most technologically deprived settings typical of most LMICs. This effort will allow generating high quality data on specific public health issues relevan to the actual environment and health needs in TBI in developing countries