BACKGROUND: 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. STUDY DESIGN: 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. RESULTS: 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). CONCLUSIONS: 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.
RCT Entities:
BACKGROUND:Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. Resuscitation with hypertonicsaline (7.5%) solutions can reduce mortality in hypotensive and brain-injured patients. STUDY DESIGN: Two multicenter, randomized, clinical trials were designed to compare hypertonicsaline 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. RESULTS: 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). CONCLUSIONS: 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.
Authors: Eileen M Bulger; Susanne May; Karen J Brasel; Martin Schreiber; Jeffrey D Kerby; Samuel A Tisherman; Craig Newgard; Arthur Slutsky; Raul Coimbra; Scott Emerson; Joseph P Minei; Berit Bardarson; Peter Kudenchuk; Andrew Baker; Jim Christenson; Ahamed Idris; Daniel Davis; Timothy C Fabian; Tom P Aufderheide; Clifton Callaway; Carolyn Williams; Jane Banek; Christian Vaillancourt; Rardi van Heest; George Sopko; J Steven Hata; David B Hoyt Journal: JAMA Date: 2010-10-06 Impact factor: 56.272
Authors: Jose-Miguel Yamal; Claudia S Robertson; M Laura Rubin; Julia S Benoit; H Julia Hannay; Barbara C Tilley Journal: Clin Trials Date: 2014-04 Impact factor: 2.486
Authors: Douglas L Andrusiek; Danny Szydlo; Susanne May; Karen J Brasel; Joseph Minei; Rardi van Heest; Russell MacDonald; Martin Schreiber Journal: Prehosp Emerg Care Date: 2015-04-24 Impact factor: 3.077
Authors: Jestin N Carlson; Dana Zive; Denise Griffiths; Karen N Brown; Robert H Schmicker; Heather Herren; George Sopko; Sara DiFiore; Dixie Climer; Caroline Herdeman; Ahamed Idris; Graham Nichol; Henry E Wang Journal: Resuscitation Date: 2018-12-17 Impact factor: 5.262
Authors: Deborah J Del Junco; Eileen M Bulger; Erin E Fox; John B Holcomb; Karen J Brasel; David B Hoyt; James J Grady; Sarah Duran; Patricia Klotz; Michael A Dubick; Charles E Wade Journal: Injury Date: 2015-01-31 Impact factor: 2.586
Authors: Leila R Zelnick; Laurie J Morrison; Sean M Devlin; Eileen M Bulger; Karen J Brasel; Kellie Sheehan; Joseph P Minei; Jeffrey D Kerby; Samuel A Tisherman; Sandro Rizoli; Riyad Karmy-Jones; Rardi van Heest; Craig D Newgard Journal: J Neurotrauma Date: 2014-05-08 Impact factor: 5.269
Authors: Craig D Newgard; Robert H Schmicker; Jerris R Hedges; John P Trickett; Daniel P Davis; Eileen M Bulger; Tom P Aufderheide; Joseph P Minei; J Steven Hata; K Dean Gubler; Todd B Brown; Jean-Denis Yelle; Berit Bardarson; Graham Nichol Journal: Ann Emerg Med Date: 2009-09-23 Impact factor: 5.721
Authors: Eileen M Bulger; Terri A Schmidt; Andrea J Cook; Karen J Brasel; Denise E Griffiths; Peter J Kudenchuk; Daniel Davis; Berit Bardarson; Ahamed H Idris; Tom P Aufderheide Journal: Ann Emerg Med Date: 2008-09-27 Impact factor: 5.721