A Safety NETT for Brain Emergencies

Members of Cincinnati’s NETT team, from left: Irene Ewing, RN, Peggy Waymeyer, RN, Sara Stark, MEd, and Principal Investigator Arthur Pancioli, MD.

In early 2007 the National Institutes of Health (NIH) established NETT – the Neurological Emergencies Treatment Trials network, a permanent research framework that currently involves 22 university medical centers throughout the United States. The Neurotrauma Center at the UC Gardner Neuroscience Institute is part of this large and ongoing program.

NETT enables physicians from many disciplines to search for better ways to treat brain emergencies, which include strokes, unrelenting seizures and blunt trauma to the brain. With the enduring framework for NETT in place, researchers can begin new neurological emergency studies whenever new therapies become available for testing.

Arthur Pancioli, MD, Professor of Emergency Medicine at UC, is principal investigator for UCNI’s involvement in the NETT framework. Inclusion in the prestigious network is one of the UCNI’s 13 national neuroscience benchmarks.

You can think of NETT as a kind of safety net. Under normal circumstances, people participate in clinical trials after careful consideration and after providing their consent. People who suffer a brain emergency, however, are unlikely to be conscious or able to provide informed consent for themselves. In such emergency cases, a relative or guardian can provide consent for the patient.

In the event that a relative or guardian cannot be reached, federal law has established a system that allows physicians – when no proven or effective treatment is available — to begin emergency investigational treatment. This is called “exception from informed consent.” This exception from informed consent will be necessary for some clinical trials that are part of NETT. If exception from consent is part of a NETT study, distribution of information about the study and public comment are required before the study begins.

Every year 1.1 million Americans suffer a devastating brain or spine emergency – about one every 28 seconds. These emergencies can be caused by strokes, seizures, vehicle crashes, falls or severe blows to the head. Every year 250,000 Americans die from brain and spinal emergencies, and thousands more suffer a loss of independence.

NETT was developed because modern medicine cannot cure all sudden brain emergencies. NETT will further researchers’ efforts to develop new therapies that can minimize the damage after an accident, stroke or seizure has occurred. Testing new therapies is part of the process of finding out which therapies works best. NETT studies underway at UCNI or soon to begin include:

  • RAMPART, the Rapid Anticonvulsant Medications Prior to Arrival Trial. RAMPART seeks to figure out whether giving anti-seizure medicine works as quickly and effectively when given as a shot in the muscle as through an IV (a tiny straw or tube in the vein).
  • ProTECT III, the Progesterone for Traumatic Brain Injury – Experimental Clinical Treatment trial. ProTECT will assess whether administering the naturally occurring hormone progesterone in patients immediately after a moderate to severe traumatic brain injury will reduce brain damage and swelling and thereby improve the patients’ outcomes.

Individuals who are opposed to being enrolled in a NETT study in the event that they were to suffer a neurological emergency can request an “opt out” bracelet by calling 513-558-NETT (0095). Leave your name and address, and a bracelet will be mailed to you.

— Cindy Starr

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