Cryostat-2
知情同意书是研究人员与一个人分享有关研究的关键事实的过程，以帮助他们决定是否参加研究beplay苹果手机能用吗研究。参加研究是自愿的，人们有权拒绝beplay苹果手机能用吗参加一项研究。在某些紧急情况下，参加研究的人由于病情而无法同意。beplay苹果手机能用吗Ceryostat-2是一项研究beplay苹果手机能用吗研究，未经同意，可以将患者纳入研究。
这项研究的目的是什么？beplay苹果手机能用吗
Worldwide, injury accounts for 5.8 million deaths every year, equivalent to one death every nine minutes and it is the leading cause of death in people under the age of 44.
创伤患者中最常见的死亡原因之一是不受控制的出血。目前，严重出血的标准治疗涉及快速注入红细胞和血液成分，例如血浆和血小板，大量。直到最近，接受大量输血（超过10品脱）的两分之一的人会因受伤而死亡。
在过去的五年中，已经进行了两项涉及出血创伤患者的重要研究，表明早期干预在受伤后更有效，可能有助于挽救生命。受伤后严重出血的患者会因其凝血系统出现问题，这意味着他们倾向于流血更多。主要问题之一是由于纤维蛋白原水平较低，这是一种通常在血液中循环的凝血蛋白。纤维蛋白原充当“胶水”，将血液凝结在一起，在低水平下，血凝块不能正确形成，并且可以继续出血。
Cryoprecipitate is a frozen blood component prepared from plasma and rich in fibrinogen. By transfusing cryoprecipitate early to replace fibrinogen levels in bleeding trauma patients, we believe blood clots will be more stable, reducing bleeding and consequently the number of deaths.
Cryostat 2 is an international, pragmatic, multi-center, parallel group, randomized controlled trial, which will run at all major trauma centers in England and at 8 international centers. At least 4 United States Level 1 trauma center sites will participate, including Memorial Herman Hospital Texas medical Center and University of Texas Health Science Center at Houston.
低温恒温器2的目的是回答一个简单的研究beplay苹果手机能用吗question of whether the addition of early cryoprecipitate to the current standard of care Major Hemorrhage Protocol improves survival from major trauma hemorrhage
研究将会发生什么？beplay苹果手机能用吗
急诊科的创伤医生将使用患者（> 16岁）首先到达时获得的信息，以预测他/她是否需要大量的血液产品。该信息包括血压，脉搏，损伤类型和超声检查，以查看腹部出血（快速检查）。对于有资格获得这项研究的患者，将通知血库将患者随机分组（像翻转硬币这样的过程）接受两组（仅与血液产物或血液产物的冷冻沉淀）之一。获得的知识可能会影响大量流血的患者输血的方式，并降低因出血性休克而导致的原本可预防的死亡量。
What are the risks of taking part in the study?
Any severely injured patient requiring massive transfusion of blood products is at risk for a number of complications, such as infection, bleeding, respiratory distress, and organ failure. The patients in the early cryoprecipitate group may have a slight increased risk of clotting complications such as deep vein thrombosis (DVT), blood clot in the lung, heart attack and stroke.
由医生，统计员和前患者组成的委员会将每3个月开会一次，以审查研究的初步数据，以评估伤害的潜力。如果该委员会认为患者受到研究的伤害，则该研究将在他们的建议下停止。
Why is it not possible to get the patients’ consent before including them in the study?
For patients requiring massive transfusion, the median time of before a patient receives blood products in the emergency department is 26 minutes. There simply isn’t enough time to both provide the timely care necessary and to obtain informed consent from family. This study will be done under emergency exception from informed consent regulations. Patients or their loved ones will be approached after the fact to seek their permission to continue in the study.
How many patients will be included in this study?
This study will enroll approximately 1500 patients and around 400 in the US.
这项研究什么时候开始？
Ceryostat-2试验已经开始在英格兰现场招募患者。预计在休斯敦审判的开始日期是2020年3月。该研究将运行2年，并在2022年6月之前完成。
如果我不希望被包括在这项研究中，如何使我的愿望知道？beplay苹果手机能用吗
If you wish to not participate in this trial, please request an “opt out” bracelet. As many of the patients who will be enrolled in this study will be unconscious or otherwise unable to communicate with the team of surgeons treating them, the bracelet must be worn to indicate that you do not wish to be enrolled in the stud. To request an opt-out bracelet, emailclinicals@uth.tmc.edu要求使用低温恒温器2选择退出手镯。
有关这项研究的更多信息：https://cryostat2.co.uk/#top
有关知情同意的有关紧急例外的更多信息visit planned emergency research without consent.