尝试权衡不同的TBI治疗方法

Host Amber Smith: 锡拉丘兹上州医科大学, New York, 邀请您成为“知情患者”, with the podcast that features experts from Central New York's only academic medical center. 我是主持人，安柏·史密斯.

Upstate was chosen to participate in a national $32 million multi-institutional clinical trial to improve patient outcomes after severe traumatic brain injury. 在这里解释这项研究是如何进行的. Devin Burke. 他是上州立大学的神经学助理教授.

欢迎来到“见多识广的病人”节目. Burke.

Devin Burke, MD: Thank you, Amber. 很高兴来到这里. 我很高兴能多谈谈试验的事.

Host Amber Smith: 现在，这个试验，这个研究，是由国家卫生研究院资助的. 除了北州，还有多少其他机构参与?

Devin Burke, MD: 这是一个多中心试验. 全国大约有50个站点. These sites are all. 一级创伤中心，比如上州医科大学, 这些地方有大量严重的创伤性脑损伤, just like Upstate.

Host Amber Smith: 一级创伤中心是什么意思? 你能解释一下为什么这对脑外伤患者很重要吗?

Devin Burke, MD: A Level 1 trauma center is a health care system that specializes in the management and resuscitation of very sick trauma patients. 才能成为一级创伤中心, you need availability of multiple specialists on call and also have some capabilities such as urgent intervention, 烧伤干预之类的.

Host Amber Smith: 所以这项研究什么时候开始，持续多久?

Devin Burke, MD: 我们正在提交IRB, 哪个是机构审查委员会的文件, 一旦通过了研究地点或全国范围的研究, 然后我们希望能尽快开始招募病人.

Part of our approval for the IRB is making sure we do enough due diligence to spread word about that we're doing this trial that is soon coming to the Syracuse community.

Host Amber Smith: 我们来谈谈创伤性脑损伤问题的范围. 关于每年有多少人因为创伤性脑损伤来到上州?

Devin Burke, MD: Traumatic brain injury is a very common disorder and even more common in certain age groups, 流动的年龄组, driving vehicles; elderly population that is susceptible to falls; and those that are in high-risk activities, such as cycling, motorcycling, contact sports, 诸如此类的事情. 那些脑外伤的人, 严重的创伤性脑损伤, 我们研究的是哪一类患者, in this trial, 是更稀有一点吗.

I would say Upstate as a whole sees about 100 people per year with 严重的创伤性脑损伤, 这就是我们在试验中要关注的患者群体.

Host Amber Smith: How do you define severe traumatic brain injury, as opposed to regular traumatic brain injury?

Devin Burke, MD: 严重创伤性脑损伤, 或者脑损伤的种类, 通常由到达时的检查确定吗, 因此，遭受严重创伤性脑损伤的人通常处于昏迷状态, not following commands and likely requiring mechanical ventilation to provide their body with enough oxygen.

这些病人都是严重的昏迷病人，他们的大脑受到了创伤.

Host Amber Smith: 我知道这是因人而异的, based on the patient, but in general, 严重创伤性脑损伤患者的预后如何?

Devin Burke, MD: 这无疑是最病态的脑损伤类型.

大约30%到40%的严重创伤性脑损伤患者, those in a coma, 那些没有醒过来的人, 会在六个月后死去. 那些存活下来的病人, 大概是60%吧, 他们中的许多人终生残疾, 大约80%的人患有终身残疾.

你的结果取决于年龄, 创伤性脑损伤之前的身体状况以及, what we hope, 是我们在重症监护室和手术室做的吗, 诸如此类的事情. 所以这是一个很大的问题，一种非常常见的疾病，非常严重和病态.

In our minds, this is the perfect kind of disease to try to do more research to provide better care for our patients.

Host Amber Smith: I wanted to ask you what sorts of procedures might be required for these patients during their hospitalization?

Devin Burke, MD: 审判本身涉及几个程序.

这是创伤性脑损伤后要做的手术之一, 预测你会做什么, 基本上就是你撞到头后大脑的压力有多高, 它会膨胀，就像任何瘀伤或伤害一样. 大脑有点不同，因为你的伤口没有肿胀的空间, 所以你大脑内的压力会增加.

One procedure that we'll do in an injury this severe is to place a monitor intracranially (within the skull) to continuously measure the pressure inside the brain. We have certain parameters that we like to keep it below and keeping it below those certain parameters has shown to improve outcome in prior studies.

With this trial, there's another monitor that we can place inside the brain that measures the oxygen present inside the brain, 这是我们在上州已经做了很多年的事情. But there has never been any high-quality, randomized controlled data to support this practice.

这才是我们研究的关键所在, is to look at outcome with the brain pressure monitor versus the brain pressure monitor and the oxygen monitor. These are the two groups that we're going to look at and see if one group does better or worse.

Host Amber Smith: 这里是纽约州推荐最近最火的赌博软件的“知情患者”播客. 我是主持人，安柏·史密斯.

我正在和神经科医生谈话. Devin Burke about a new study designed to improve patient outcomes after severe traumatic brain injury.

参与研究的病人, how will they be able to give consent to be in the study if they're comatose with a traumatic brain injury?

Devin Burke, MD: 这是一个很好的问题，这也是我们实验的独特之处之一.

所以当你得了这种病, that really the patients with severe traumatic brain injury are unconscious and unwilling or unable to give their consent, 政府在90年代通过了一项法律，试图纠正这种冲突. 你有这些疾病, 如创伤性脑损伤或其他紧急疾病, 需要高质量的研究, but you have the problem that the patients that would be enrolled are too sick to be awake or to give consent.

为了解决这个冲突, FDA(食品和药物管理局)通过了一项法律(技术上), 它创造了一个例外，叫做《推荐最近最火的赌博软件》. This is designed to try to improve the quality of research done in patients with emergent illness. It comes with a lot of specifiers and a lot of requirements because what we're asking for is to enroll a patient into a trial without their consent, 所以这是一个相当严肃的冒险. 所以它要求你做的事情是，首先，咨询整个社区. 让他们知道这个试验正在进行, 征求他们的意见、想法和意见, 并真正接触到社区内的各种人口统计数据.

年轻人——我们去了雪城大学, 我们和那边的神经科学俱乐部谈了谈，听取了他们的意见, because the youth, 这是一个创伤性脑损伤的高风险人群.

We've also talked to elderly populations and received their opinions on the ethics of this trial. 我们被要求完成其中的六个项目，我们已经完成了所有这些项目，这很棒.

我们被要求做的第二件事是公开披露事件, 公开我们即将进行的一项试验, 提前通知别人. 我们做了一些新闻发布，这个播客也很有帮助. “知情患者”在传播这一重要信息方面发挥着至关重要的作用. 我们为此感谢你.

Host Amber Smith: Well, you said, or you described, 你会比较这个测试的颅内压, 进行颅内压测试和脑组织氧合测试. 作为从业者的你, do you have kind of a gut feeling of which one you think is going to be a better way to determine which patients are going to do well?

Devin Burke, MD: 在上州立大学, 在神经危重症监护室, 我们放置颅内氧导管已经有一段时间了. 这是一些较低级别的证据, 一些回顾性研究, 一些相关研究, some animal studies that showed that increasing the oxygen or monitoring the amount of oxygen in the brain can possibly lead to a better outcome, 所以我们希望情况就是这样.

It also gives us another tool to try to optimize this disorder that has such high morbidity and mortality (sickness and death). However, 为了进行审判, 需要有一个小组来决定其中一个不比另一个好. 我们称这一原则为“平衡”.“为了进行试验, 目前还不清楚哪种治疗方法更好, 因为在这个试验中, 我们将单独通过颅内压监测来治疗病人, so it has to be clear in the evidence that there is a gap and there is not a certain answer, but obviously, 我们希望我们能有更多的工具来治疗这些病人.

Host Amber Smith: 好吧，请告诉我们这实际是如何发生的. 审判开始时, 一个病人被送到急诊科患有创伤性脑损伤, what happens then?

Do they call you?

Devin Burke, MD:

我想强调，这需要全村人的努力. 这是一个多学科的冒险. So, the first people other than the EMTs (emergency medical technicians) that the patient will see is the, 急救医生和急救小组. 所以急救小组通常会提醒创伤外科医生，这里有创伤, 如果创伤可能涉及到大脑, 而且有严重的创伤性脑损伤的威胁, 神经外科也会收到通知. And our trauma and emergency team will both assess the patient for any life-threatening injuries that require resuscitation, 然后我们会开始考虑病人的试验.

所以会有一些标准. 标准将主要围绕考试的样子? 病人是否昏迷, and if so, 然后我们希望急诊和创伤科的同事提醒我们的研究团队. 我们会对病人进行评估，让他参加试验.

It's the easier end because truly what we're doing in the trial is very similar to what we do on a daily basis. 并没有太大的变化. It's just incorporating these patients in a more systematic way to evaluate if the treatments that we do, if they help or not.

Host Amber Smith: 其中一些患者不仅仅是创伤性脑损伤. 他们也会有其他的伤病. Are they still able to be in the trial if they're having their other injuries taken care of before?

Devin Burke, MD: 是的，大多数人都会. We are always in close consultation with our trauma team to evaluate the safety of enrolling in the trial.

如果其他伤没有生命危险的话, then yeah, sure, 他们可以参加试验. However, If there are urgent surgical emergencies that need to be taken care of prior to treatment or monitoring of the severe traumatic brain injury, 到时候会处理的, 病人很可能会, 没有被纳入试验. 所以，威胁生命的问题总是优先考虑的.

Host Amber Smith: 你如何决定病人参加哪一组试验? 要么是刚测过颅内压的那个，要么 ...

Devin Burke, MD: Yeah, 这是一个随机试验, 所以一旦病人符合纳入标准, 这些信息将被发送到我们的中心枢纽, 计算机会随机选择一种治疗策略. So the clinican, 和床边护理, 我们不知道病人被分到哪一组.

Host Amber Smith: 他们在医院的整个时间里都是在同一只手臂上，对吧? 这就是问题的关键.

Devin Burke, MD: 完全正确. Yeah.

Host Amber Smith: 我很感谢你抽出时间跟我们说这件事. Burke.

Devin Burke, MD: Of course. 我很乐意跟你谈谈. 我对创伤性脑损伤很感兴趣，我们真的需要更好的选择. 我们需要进行研究, 我们很高兴能站在上州立大学神经重症监护室的最前沿. And I just want to shout out to all the nurses in the Neurocritical Care Unit that work hard every day to provide good care to our patients. 非常感谢大家.

Host Amber Smith: 我的嘉宾是神经病学助理教授. Devin Burke.

“知情的病人”是一个关于健康的播客, 科学与医学, 由锡拉丘兹上州医科大学为您带来, New York, 由吉姆·豪制作.

在upstate找到我们之前的剧集.edu/informed.

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