Selected Projects

SIREN LogoSIREN – Strategies to Innovate Emergency Care Clinical Trials Network

UTHealth PI: Dr. Elizabeth Jones

Sponsored by the National Institutes of Health, the objective of the SIREN network is to conduct multi-center clinical trials on the spectrum of emergent health conditions. The national network includes 11 clinical hubs, a coordinating center at the University of Michigan and a data coordinating center at the Medical University of South Carolina. Dr. Jones is the principal investigator of the UTHealth Emergency Medicine site. For more information on the SIREN network visit here: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-16-016.html


NETT - Neurological Emergencies Treatment Trials network logoNETT – Neurological Emergencies Treatment Trials network

UTHealth PI: Dr. Elizabeth Jones

The Neurological Emergencies Treatment Trials (NETT) Network is a large network dedicated to conducting clinical trials in neurologic emergencies. The NETT is made up of 22 hubs plus affiliated  spoke sites.


ESETT - Established Status Epilepticus Treatment Trial logoESETT – Established Status Epilepticus Treatment Trial (ESETT)

UTHealth PI: Dr. Elizabeth Jones

This is a multicenter, randomized, double-blind, comparative effectiveness study of fosphenytoin, levetiracetam, and valproic acid in subjects with benzodiazepine-refractory status epilepticus. Patients will be recruited by two national emergency research networks: NETT and Pediatric Emergency Care and Applied Research Network (PECARN).


POINT - Platelet-Oriented Inhibition in New TIA and Minor Ischaemic Stroke Trial logoPOINT – Platelet-Oriented Inhibition in New TIA and Minor Ischaemic Stroke Trial

UTHealth PI: Dr. Elizabeth Jones

POINT is a randomized, double-blind, multicenter clinical trial to determine whether clopidogrel 75mg/day (after a loading dose of 600mg) is effective in improving survival from major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours of new ischemic symptoms of TIA or minor ischemic stroke.


SHINE: Stroke Hyperglycemia Insulin Network Effort logoSHINE: Stroke Hyperglycemia Insulin Network Effort

UTHealth PI: Dr. Elizabeth Jones

This is a multicenter, prospective, randomized, controlled trial, with blinded outcomes. It aims to determine the efficacy and provide further safety data on the use of insulin infusion therapy for glucose control in hyperglycemic acute ischemic stroke patients. Treatment with insulin infusion will be given within 12 hours of symptom onset. The primary outcome to be assessed at 90 days will be the difference in favorable outcome measured by the modified Rankin Scale score in the insulin infusion group compared to the control group.


PART - Pragmatic Airway Resuscitation Trial logoPART – Pragmatic Airway Resuscitation Trial

UTHealth PI: Dr. Henry Wang

This multi-center study will compare the efficacy of two airway devices that are currently being used by Emergency Medical Services (EMS) agencies in the pre-hospital setting for out-of-hospital cardiac arrest. The two airway devices being studied are the endotracheal tube and a laryngeal tube, which is inserted into the esophagus and diverts air to the lungs by blocking its entry to the esophagus and stomach. Both devices are approved by the Food and Drug Administration (FDA) Agency. The study will be conducted in six locations across the United States and will enroll a total of 3,000 patients across the ROC clinical trials network.

For more information visit PART


REGARDS-Sepsis logoREGARDS-Sepsis

PI: Dr. Henry Wang

The NIH-funded REGARDS (REasons for Geographic And Racial Differences in Stroke) study is one of the largest ongoing national cohort studies of community-dwelling individuals in the United States. Encompassing representation from all regions of the continental US, the REGARDS study includes 30,000+ individuals > 45 years old from across the nation. The objective of the REGARDS-Sepsis study is to identify individual and community-level risk factors for sepsis.

For more information visit REGARDS-Sepsis.


Vapotherm® Randomized Clinical Trial

PI – Dr. Pratik Doshi

This was multicenter, randomized trial of adults presenting to the emergency department (ED) with respiratory failure requiring noninvasive positive-pressure ventilation. Patients were randomly assigned to high-velocity nasal insufflation (HVNI) or noninvasive positive-pressure ventilation using an oronasal mask, BIPAP. An advantage of high-velocity nasal insufflation is that patients do not have to tolerate the continuous use of a tight-fitting mask and hence, can converse and eat during its application; the trial sought to compare HVNI’s therapeutic efficacy against widely used BIPAP therapy. The primary outcome was therapy failure at 72 hours after enrollment in this non-inferiority trial.


PECARN logoPECARN – Validation Study of PECARN Clinical Decision Rule to Identify Children with Intra-abdominal Injuries

UTHealth PI: Dr. Irma Uglade

This is a prospective multi-center study of children with blunt torso trauma with a goal of validating the previously identified high-risk and low-risk indicators of intra-abdominal injury (IAI). The long-term objective of the original study was to derive, disseminate, and implement decision support tools to optimize the evaluation of children with blunt torso trauma, leading to reduced morbidity and mortality. The overall objective is to develop a clinical decision rule for the appropriate use of abdominal computerized tomography (CT) scanning in children with blunt torso trauma.


PECARN – Validation Study of PECARN Clinical Decision Rule for Minor Head Injury

Site PI: Dr. Irma Ugalde

This multicenter, prospective, non-interventional study aims to validate the clinical decision tool for identifying children who are at very low risk of clinically important traumatic brain injuries after minor head trauma. Like the original PECARN Childhood Head Trauma: Neuroimaging Decision Rule study, the current study enrolls pediatric patients seeking a consultation within 24 hours of head trauma with a Glasgow Coma Scale scores of 14–15. Once validated, there will be additional evidence that there are certain patients who are at very low risk for an injury that requires intervention. Thus, use of the rule will help decrease the use of computerized tomography (CT) scanning in children, which may pose long-term risks.


CLOVERS – Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

UTHealth PI: Dr. Henry Wang

The NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Network is a collaborative focused on the development and conduct of randomized controlled clinical trials to prevent or treat acute lung injury. The CLOVERS study compares two methods of resuscitation in patients with septic shock. One method is the first provide intravenous fluids to the patient, and then use vasopressors. The other method is to use the vasopressors first, then use fluids.


XePOHCAS – Xenon for Post Out of Hospital Cardiac Arrest Syndrome

UTHealth PI: Dr. Henry Wang

Brain injury may occur after sudden cardiac arrest. This clinical trial will test the effectiveness of inhaled xenon gas for protection against brain injury in initial survivors of out-of-hospital cardiac arrest.


AURORA LogoAURORA

UTHealth PI: Dr. Paulina Sergot

The AURORA study is a major national research initiative to improve the understanding, prevention, and recovery of individuals who have experienced a traumatic event. AURORA is supported by more than 30 million dollars in funding from NIH, private foundations, and partnerships with leading tech companies such as Mindstrong Health and Verily Life Sciences, the health care arm of Google’s parent company Alphabet. Five thousand participants who present to a consortium of the leading emergency departments in the nation will be enrolled. Trauma survivors participating in AURORA will receive initial evaluation in the emergency department, followed by intensive multimodal follow-up over a one year period. The wealth of first-in-kind information gained from this study will be used to develop predictive and diagnostic biomarkers and urgently needed preventive/treatment interventions for civilian trauma survivors and military veterans.


ACTS – Ascorbic Acid Corticosteroids and Thiamine in Sepsis Trial

This multicenter clinical trial aims to determine whether the combination of ascorbic acid (vitamin C), thiamine (vitamin B1), and corticosteroids improves the trajectory of organ failure and reduces mortality in patients with sepsis and septic shock as compared to placebo.


RADICAL II – Rapid Diagnostic in Categorizing Acute Lung Infections

UTHealth PI: Dr. Irma Uglade

This multicenter cross sectional study seeks to evaluate the diagnostic accuracy of a host response test to categorize the etiology of acute respiratory illnesses.