Brasel Karen J, Bulger Eileen, Cook Andrea J, Morrison Laurie J, Newgard Craig D, Tisherman Sam A, Kerby Jeffrey D, Coimbra Raul, Hata J Steven, Hoyt David B
Department of Surgery, Division of Trauma/Critical Care, Medical College of Wisconsin, Milwaukee, WI 53226, USA.
J Am Coll Surg. 2008 Feb;206(2):220-32. doi: 10.1016/j.jamcollsurg.2007.07.020. Epub 2007 Oct 18.
Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. Resuscitation with hypertonic saline (7.5%) solutions can reduce mortality in hypotensive and brain-injured patients.
Two multicenter, randomized, clinical trials were designed to compare hypertonic saline resuscitation with or without dextran with conventional isotonic resuscitation in patients with hypovolemic shock or traumatic brain injury. During a 3-year period, 5,848 patients will be randomized, with a primary end point of 28-day survival in the hypovolemic shock cohort and 6-month neurologic outcomes in the traumatic brain injury cohort.
This is a report of the study design and implementation of 2 large-scale prehospital intervention trials from the Resuscitation Outcomes Consortium that qualify for exception from informed consent required for emergency research outlined in FDA regulation 21CFR50.24 and the Canadian Tri-Council Agreement for research in emergency health situations (Article 2.8).
We have successfully designed and implemented two prehospital intervention trials. The proc-ess has helped define the numerous challenges that must be overcome to pursue exception from informed consent resuscitation research in the prehospital setting. The results of these studies will hopefully advance and improve the early care of the severely injured patient.
创伤是1至44岁北美人群的首要死因。用高渗盐水（7.5%）溶液进行复苏可降低低血压和脑损伤患者的死亡率。
两项多中心、随机临床试验旨在比较在低血容量性休克或创伤性脑损伤患者中，高渗盐水复苏联合或不联合右旋糖酐与传统等渗复苏的效果。在3年期间，将对5848例患者进行随机分组，低血容量性休克队列的主要终点为28天生存率，创伤性脑损伤队列的主要终点为6个月神经学转归。
本文报告了复苏结局联盟两项大规模院前干预试验的研究设计与实施情况，这两项试验符合美国食品药品监督管理局法规21CFR50.24及加拿大三理事会紧急健康状况研究协议（第2.8条）中紧急研究所需知情同意豁免的条件。
我们成功设计并实施了两项院前干预试验。该过程有助于明确在院前环境中开展知情同意豁免复苏研究必须克服的诸多挑战。这些研究结果有望推动并改善对重伤患者的早期救治。
