Network Aims for Quicker Neurological Emergency Treatment
Published July 2007
Every 28 seconds in the United States, someone suffers from one of the eight most common neurological emergencies, including stroke, seizures and traumatic brain injury.
That's over 1 million people a year. And every two minutes, one of them dies (250,000 people per year).
Research has shown that rapid treatment for those suffering from neurological emergencies increases their chances for a more successful recovery. That's why UC, along with 10 other academic medical centers, will serve as regional coordinating centers for hospitals in their area. They will create a network, called the Neurological Emergencies Treatment Trials (NETT) Network, of over 70 hospitals nationwide that will collectively perform the latest clinical research on these problems.
"There are lots of good trial networks in existence already-especially those that are disease-specific, such as for cancer-but this is the first network specifically focused on neurological emergencies," says Arthur Pancioli, MD, associate professor and vice chair for research in emergency medicine.
NETT, Pancioli explains, involves multidisciplinary medical professionals, including emergency medicine physicians, emergency medical technicians, nurses, neurologists, neuroradiogists and neurosurgeons.
Pancioli is the principal investigator for the Cincinnati hub and coinvestigator for the network's clinical coordinating center. He also serves on the NETT executive committee.
"By participating in NETT, we're offering cutting-edge therapy treatments to people in our region," says Pancioli.
The advantage of having a large network of facilities studying emergency treatments "allows us to enroll high numbers of patients more quickly," he says.
"For example, our stroke team members recently conducted a study of non-traumatic intracranial hemorrhage within three hours of onset at 16 hospitals in Greater Cincinnati," explains Pancioli. "We found only 133 patients within the prescribed time in our system.
"So even if as many as half of them could be enrolled in a clinical trial, it would take our team 60 years to complete the 1,000-patient trial necessary to answer a clinically very important question. If, however, we do such a study throughout the NETT network we can complete the trial in five years."
The first NETT phase-3 trial will begin locally in mid-July. The trial, called ALIAS (Albumin in Acute Stroke Trial), will study high-dose human albumin to determine if this therapy increases favorable outcomes for ischemic stroke patients.
Currently, there's only one FDA-approved acute stroke medication (tPA) and it's only effective if given within three hours of a stroke.
"Albumin can be given within five hours of a stroke to patients treated with or without tPA," says Pancioli. "Ideally, if proven effective, this would give us an additional treatment for stroke."
Pancioli and his colleagues anticipate initiating the study at up to nine area hospitals.
Additional NETT clinical trials are also expected on conditions such as Bell's palsy, spinal cord injury, traumatic brain injury and stroke, but it could take up to a year or more before additional trials begin.
"In neurological emergencies, informed consent is very important," says Pancioli. "In some cases we will need to use the federal regulations for 'exception to consent for emergency research.' In those cases we will thoroughly educate everyone who is potentially involved in the research, from the community through all levels of medical practitioners."
NETT is funded by the National Institutes of Neurological Disease and Stroke (NINDS), which has committed $26.5 million to NETT over five years.
In addition to UC, hubs for the NETT are at:
· Emory University
· Henry Ford Hospital Medical College of Wisconsin
· Temple University
· University of Arizona
· University of California San Francisco
· University of Kentucky
· University of Minnesota
· University of Pennsylvania
· Wayne State University
The clinical coordinating center is the University of Michigan and the statistical and data management center is the Medical University of South Carolina.