CLINICAL TRIAL: COBRIT: CITICOLINE BRAIN INJURY TREATMENT TRIAL

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者的研究机构。 与安慰剂相比，在创伤性脑损伤后用胞二磷胆碱治疗90天改善了认知缺陷的恢复，如在损伤后90天通过核心神经心理成套测试所测量的。 近1300例急性复杂性（即头部CT显示有损伤证据）轻度（格拉斯哥昏迷量表（GCS）评分13-15），中度（GCS 9-12）或重度（GCS 3-8）TBI的患者将从组成TBI临床试验（TBI-CT）网络的八个临床站点招募，所述TBI临床试验（TBI-CT）网络包括弗吉尼亚联邦大学医学中心、马里兰州大学、坦普尔大学、田纳西大学、亚拉巴马伯明翰大学、德克萨斯大学西南医学中心、匹兹堡大学和华盛顿大学。 符合所有入组标准的受试者将在双盲条件下随机分配接受1000 mg bid胞磷胆碱或安慰剂bid。 第一剂将在受伤后24小时内给予，治疗将持续90天。将在损伤后30、90和180天评估功能结局。 主要结局由一组指标组成，将使用90天时的总体统计数据作为复合指标进行分析。该复合测量由以下核心组合组成：扩展格拉斯哥结果量表（GOS-E）、控制性口语词汇联想测试（COWAT）、处理速度指数（PSI）、连线测试A部分、连线测试B部分、Stroop测试、加州言语学习测试（CVLT）和数字广度，并使用全局统计量进行分析。 次要结局将包括生存率、毒性和恢复率。 有一些证据表明，一种名为Apo-E基因的基因可能与TBI后的恢复有关。其他基因也可能影响头部受伤后的恢复和愈合。 COBRIT研究的一部分是确定Apo-E基因是否与恢复和对胞磷胆碱的反应有关。另一部分是储存冷冻的血液和脑脊液样本，以便在有新信息时进行检测。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Compared to placebo, treatment with Citicoline for 90 days following a traumatic brain injury improves recovery of cognitive deficits as measured by a core neuropsychological battery at 90 days post-injury. Nearly 1300 subjects with an acute complicated (i.e. with evidence of injury on head CT) mild (Glasgow Coma Scale (GCS) score 13-15), moderate (GCS 9-12) or severe (GCS 3-8) TBI will be recruited from eight clinical sites composing the TBI Clinical Trials (TBI-CT) Network that includes the Virginia Commonwealth University Medical Center, University of Maryland, Temple University, University of Tennessee, University of Alabama Birmingham, University of Texas Southwestern Medical Center, University of Pittsburgh, and University of Washington. Participants who have met all enrollment criteria will be randomly assigned to receive 1000 mg bid Citicoline or placebo bid under double-blind conditions. The first dose will be given within 24 hours of injury and treatment will continue for 90 days. Functional outcome will be assessed at 30-, 90- and 180-days post-injury. The primary outcome consists of a set of measures that will be analyzed as a composite measure using a global statistic at 90 days. This composite measure is comprised of the following core battery: Extended Glasgow Outcome Scale (GOS-E), Controlled Oral Word Association Test (COWAT), Processing Speed Index (PSI), Trail Making Test parts A, Trail Making Test part B, Stroop Test, California Verbal Learning Test (CVLT), and Digit Span and analyzed using the global statistic. Secondary outcomes will include survival, toxicity, and rate of recovery. There is some evidence to suggest that a form of a gene called Apo-E gene may be associated with recovery after a TBI. It is likely that other genes may also influence the amount of recovery and healing after a head injury. One part of the COBRIT study is to determine whether the Apo-E gene is associated with recovery and with response to Citicoline. Another part is to store frozen blood and CSF samples for later testing as new information becomes available.