Clinical Trials

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Current Trials

ESETT - Established Status Epilepticus Treatment Trial

ESETT is a multicenter, randomized, double-blind, comparative effectiveness study of fos-phenytoin, levetiracetam, and valproic acid in subjects with benzodiazepine-refractory status epilepticus (people who do not stop seizing after 5 minutes). Emergency department care of Established Status Epilepticus (ESE) in the US is not the same everywhere. Doctors use their judgment, but what treatment will work best is not known. The purpose of this study is to find out which of three commonly used medicines given in the emergency department for ESE is safer and more effective. Normally, researchers get permission before a person can be included in a study. A person having a seizure will not be able to give consent. Since a seizure that will not stop on its own must be treated quickly, there will not be enough time to locate and talk to the person’s legal representative about the study. All patients will be enrolled in the study without his/her legal representative’s consent. This is called “Exception from Informed Consent” (EFIC). Once the representative is located or the patient wakes up, they will be told about the study and asked to give their permission to continue in the study.

If you would like to opt out of the possibility of being enrolled in the ESETT trial, please call 612-624-8280 for more information.

Learn more about the ESETT trial.

Minnesota NETT Hub participating hospitals:

  • Fairview Southdale Hospital
  • Hennepin County Medical Center
  • Mayo Clinic - St. Mary's Campus
  • Regions Hospital
  • University of Minnesota Masonic Children's Hospital
  • University of Minnesota Medical Center - Fairview

POINT - Platelet-Oriented Inhibition in New TIA and minor ischemic stroke Trial

POINT is a randomized, double-blind, multicenter trial to determine whether clopidogrel 75mg/day (after a loading dose of 600mg) is effective in improving survival free from major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours time last known free of new ischemic symptoms of TIA or minor ischemic stroke in subjects receiving aspirin 50-325mg/day.

Learn more about the POINT trial.

Minnesota NETT Hub participating hospitals:

  • Abbott Northwestern Hospital
  • Essentia Health - Duluth
  • Essentia Health - Fargo
  • Fairview Southdale Hospital
  • Hennepin County Medical Center
  • Mayo Clinic
  • Regions Hospital
  • Ridgeview Hospital
  • Two Twelve Medical Center
  • United Hospital
  • University of Kansas Medical Center
  • University of Minnesota Medical Center - Fairview

SHINE - Stroke Hyperglycemia Insulin Network Effort

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. The rates of symptomatic hypoglycemia with prolonged neurological worsening as well as asymptomatic hypoglycemia will be assessed. The secondary outcomes will assess additional neurological and functional outcomes. This highly collaborative research program is nearly guaranteed to advance the field of stroke care.

Learn more about the SHINE trial.

Minnesota NETT Hub participating hospitals:

  • Hennepin County Medical Center
  • University of Kansas Medical Center
  • University of Minnesota Medical Center - Fairview

Community VOICES (3): Community VOICES on informed consent in emergency situation

The VOICES trial reports and anaylzes the various methods of implementing exception from informed consent trials, from trial start up to close. VOICES is currently the only non-interventional, non-NETT trial in the Department of Emergency Medicine.

Learn more about the VOICES trial.

Closed to Enrollment Trials

ATACH-II - Antihypertenseive Treatment of Cerebral Hemorrhage

ATACH-II is an international trial of very early blood pressure lowering with IV nicardipine to two different systolic blood pressure targets in hypertensive patients with moderate sized parenchymal intracerebral hemorrhage.

Learn more about the ATACH-II trial.

Minnesota NETT Hub participating hospitals:

  • Essentia Health - Duluth
  • Fairview Southdale Hospital

Completed Trials

ProTECT - Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment

Traumatic brain injury (TBI) is a major cause of premature death and disability worldwide. With the exception of mannitol, no therapy has been found to be effective in reducing mortality and improving functional outcomes. Progesterone is a steroid found to have powerful neuroprotective properties in multiple animal models of brain injury. Based on encouraging pilot clinical trial results, the ProTECT trial was designed to determine the efficacy and confirm safety of this treatment in adults with moderate to severe TBI. Patients were enrolled into this study within 4 hours of injury. This study was conducted exclusively at Level 1 Trauma Centers.

Learn more about the ProTECT trial.

Minnesota NETT Hub participating hospitals:

  • Hennepin County Medical Center
  • North Memorial Medical Center
  • Regions Hospital

ALIAS - Albumin in Acute Stroke Trial

Stroke is the leading cause of death and disability in the United States. The purpose of the ALIAS trial is to evaluate the effectiveness of high-dose, intravenous human serum albumin.  Human serum albumin is a natural protein already in clinical use for a variety of indication. 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.

Learn more about the ALIAS trial.

Minnesota NETT Hub participating hospitals:

  • Fairview Southdale Hospital
  • Hennepin County Medical Center
  • University of Minnesota Medical Center - Fairview

RAMPART - Rapid Anticonvulsant Medication Prior to Arrival Trial

Status epilepticus, a condition of persistent seizures that do not stop, is a neurologic emergency associated with death and significant disability. Paramedics treat status epilepticus with anti-seizure medicine, but giving medicine through a vein can be difficult or slow in a seizing patient. This study will determine (1) if the anti-seizure drug midazolam given as a shot in the muscle stops seizures as well as the anti-seizure medicine lorazepam given directly into a vein, and (2) the rapidity and safety of these two medicines given in these different ways.

Patient enrollment began on Monday July 20, 2009 within the Hennepin EMS service only. EMS personnel responding to calls for patients with Status Epilepticus were trained in the RAMPART protocol and evaluated patients for possible enrollment in this emergency medicine research study. Enrollment was completed January 2011. This study's results were published in the New England Journal of Medicine, February 16, 2012, entitled: Intramuscular versus Intravenous Therapy for Prehospital Status Epilepticus.

Learn more about the RAMPART trial.

Minnesota NETT Hub participating hospitals:

  • Abbott Northwestern Hospital
  • Fairview Southdale Hospital
  • Hennepin County Medical Center
  • Park Nicollet Methodist Hospital
  • University of Minnesota Medical Center - Fairview