ONGOING MAJOR PROJECTS
- SIREN (Strategies to Innovate EmeRgENcy Care Clinical Trials Network) is a new initiative of the National Institutes of Health to advance critical emergency medicine research. SIREN provides infrastructure for large multi-site clinical trials to improve outcomes for patients with neurologic, heart, lung, blood and trauma emergencies, in all stages of emergency care, from pre-hospital emergency medical services to hospital EDs, trauma systems and emergency operative interventions. SIREN will allow rigorous comparative effectiveness studies and assessments of novel therapies. The University of Arizona is one of a team of six national institutions to serve as hubs for SIREN.
- EPIC and EPIC4Kids (Excellence in Prehospital Injury Care) is a public health initiative that is a partnership between the Arizona Department of Health Services (ADHS), the AEMRC, and more than 110 EMS agencies throughout Arizona. The Program is implementing and evaluating the EMS traumatic brain injury treatment guidelines across the state of Arizona. The evaluation of the impact of the TBI guidelines is funded by the NIH.
- HeartRescue is part of the Save Hearts in Arizona Registry and Education Program (SHARE) and is focused on improving survival from sudden cardiac arrest throughout the state. It is a partnership between the ADHS, the UA Sarver Heart Center, the AEMRC, and over 100 EMS agencies.
- HOBIT (Hyperbaric Oxygen Brain Injury Treatment Trial) is a Phase II adaptive clinical trial designed to test preclinical and clinical investigations that have indicated that hyperbaric oxygen therapy (HBO2) has a positive impact on reducing brain injury and improving outcomes in severe TBI. By markedly increasing oxygen (O2) delivery to the traumatized brain, HBO2 can reverse the lack of O2 that precipitates cellular energy failure and subsequent brain cell death. Eight different treatment regimens will be used to help optimize the combination of HBO2 treatment parameters for a subsequent Phase III trial. A total of 200 subjects will be enrolled over 3 1/2 years. This trial is being conducted at HonorHealth Scottsdale, and is being supported and sponsored by the University of Arizona and the SIREN Network and is being funded by the National Institutes of Neurologic Disease and Stroke.
- POINT (Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke Trial) is an NIH-funded trial, administered by the Neurological Emergencies Treatment Trials program (NETT). The purpose is to determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death). The NETT is a 17-site nationwide network created to conduct large clinical trials to reduce the burden of very acute injuries and illnesses affecting the brain, spinal cord and peripheral nervous system. This network provides the basis for conducting efficient studies in these environments. Results to be published.
- ATACH-II (Antihypertensive Treatment of Acute Cerebral Hemorrhage) was an NIH-funded trial, administered by the Neurological Emergencies Treatment Trials program (NETT), to determine the therapeutic benefit of intensive SBP treatment compared with standard SBP treatment in reducing the proportion of patients with death and disability (mRS of 4-6) among subjects with ICH treated. http://www.nejm.org/doi/full/10.1056/NEJMoa1603460
- ProTECT (Progesterone for the treatment of traumatic brain injury) was an NIH-funded trial, administered by the Neurological Emergencies Treatment Trials program (NETT). ProTECT tested the administration of 96 hours of IV progesterone for the treatment of moderate to severe blunt Traumatic Brain Injury (TBI). After all patients completed the study, the data was cleaned and analyzed. There was no significant difference in the progesterone-treated group when compared to placebo-treated group in survival and favorable outcomes. Arizona Hub hospitals that participated in the trial were: The University of Arizona Medical Center-University Campus, Scottsdale Healthcare Osborn, Maricopa Medical Center, Banner Good Samaritan Regional Medical Center, and University of New Mexico Albuquerque. http://sitemaker.umich.edu/protect/home
- BioProTECT (Biomarkers of Injury and Outcome in TBI) was an effort to find biomarkers in the bloodstream that could provide physicians with a quick and accurate method to assess severity of traumatic brain injury (TBI) and help monitor effectiveness of therapies. This study has been completed and results are being analyzed. Results will be forthcoming.
- RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial) was an NIH-funded trial, administered by the Neurological Emergencies Treatment Trials program (NETT). The purpose of this study was to find out which type of routine care is the best way for paramedics to stop someone from seizing. Two similar medicines—midazolam and lorazepam—were used. Both were already used by paramedics in the field and by doctors in the hospital to stop seizures. Lorazepam is commonly given IV, and midazolam is commonly given as a shot in the muscle. The study found that 73 percent of patients in the group receiving midazolam were seizure-free upon arrival at the hospital, compared to 63 percent of patients who received IV treatment with lorazepam. Patients treated with midazolam were also less likely to require hospitalization than those receiving IV lorazepam. Among those admitted, both groups had similarly low rates of recurrent seizures. http://rampart.umich.edu/rampart/home Prehospital protocols guiding care of seizure patients have been changed due to the findings of the trial. https://www.aems.org/red-book-terms
- ALIAS (High-Dose Albumin Therapy for Neuroprotection in Acute Ischemic Stroke) was an NIH-funded trial, administered by the Neurological Emergencies Treatment Trials program (NETT). The purpose of the ALIAS trial is to evaluate the effectiveness of high-dose, intravenous human serum albumin. In animal laboratory studies, it has been shown that it reduces the size of the infarction (amount of tissue death) in the brain and improves neurological function after a stroke and also decreases or eliminates the brain swelling that may occur; these effects may reduce or prevent the brain damage resulting from a stroke in humans.
Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines in Children: The EPIC4Kids Study
3/1/2012 - 2/29/2016
Aim: To test the hypothesis that statewide implementation of the nationally-vetted, evidence-based TBI guidelines in the 911 EMS system will significantly reduce mortality and improve non-mortality outcomes in children (age < 18) with severe TBI. $851,391
Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
3/1/2011 - 2/29/2016
Aim: To test the hypothesis that statewide implementation of the nationally-vetted, evidence-based TBI guidelines in the 911 EMS system will significantly reduce mortality and improve non-mortality outcomes in adults and mature children (age ≥18) with severe TBI. $2,773,320
Medtronic Research Foundation
10/2010 - 9/2015
Aim: This grant funds the implementation and analysis of implementation of broad, widespread changes in the prehospital and in-hospital critical care of out-of-hospital cardiac arrest as a statewide effort in Arizona. This includes the integration of OHCA care across nearly 100 EMS agencies and over 30 hospitals. $2,500,000
Development of Real-Time Audiovisual Feedback (RTAVF) for Improving EMS Care of Intubated TBI Patients
(Co-PIs: Spaite, Bobrow)
8/2012 - 7/2017
Aim: To develop real-time audio-visual feedback (RTAVF) systems using End-Tidal CO2 for improving the ventilatory management of severe TBI patients who are intubated. Total Funding: $400,000
Development of Real-Time Audiovisual Feedback for Improving EMS Care of Intubated TBI Patients
(Co-PIs: Bobrow, Spaite)
8/2012 - 7/2017
Aim: To develop RTAVF using End-Tidal CO2 for improving the ventilatory management of severe TBI patients who are intubated. Total Funding: $425,000
ProTECT (Progesterone for Traumatic Brain Injury)
NIH/NINDS: 1U0NNS062778-01/3001300049-PIII; NCT00822900
2/2009 - 2/2014
This is a clinical trial designed to determine the effectiveness of intravenous progesterone initiated within 4 hours of injury and administered for 96 hours as compared to placebo at improving functional outcome in patients with moderate to severe traumatic brain injury.
Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART)
NIH/NINDS: U01NS056975/3000691503-RPT07 NINDS
1/2008 - 6/2012
This trial, a study of the NETT/AzNETT, is an exception from informed consent (EFIC) RCT comparing IM midazolam and IV lorazepam in the prehospital treatment of status epilepticus. As the PI, Dr. Spaite has been responsible for developing the EMS collaborations, leading the EFIC process, developing relationships with all hospitals receiving study patients, implementation of the trial, EMS personnel training, study protocol compliance, and overall leadership of all aspects of the trial at the AzNETT hub. $450,000 (direct costs)
Arizona Neurological Emergencies Treatment Trial (AzNETT)
NIH/NINDS: 5U10NS058962 NINDS
9/1/06 - 8/31/11
This five-year grant supports the Arizona neurological emergencies clinical trials hub at the University of Arizona with coordinated research in several EMS systems and many hospitals in across the state. AzNETT is one of 17 centers in the nation. $1,500,000 (direct costs)
American Heart Association: Comparison of the Effectiveness of Ultra-Brief and Brief Hands-Only CPR Video Training With and Without Psychomotor Skill Practice for Lay Responders: A Controlled Randomized Study
1/1/2009 - 6/30/2010
This study evaluated the impact of very short training sessions on the likelihood of actually performing CPR when needed. The study concluded that laypersons exposed to very short Hands-Only CPR videos are more likely to attempt CPR and show superior CPR skills than untrained laypersons. $100,000.