Back in the '90s, a breakthrough drug revolutionized the treatment of strokes caused by a clot in a blood vessel to the brain.
More recently, doctors added catheter procedures to the arsenal against ischemic strokes, the most common type. The other kind, hemorrhagic strokes -- when a weakened vessel ruptures and blood seeps into the brain -- are less prevalent but more devastating.
FASTEST studyWhat: Study of the use of a drug, recombinant Factor Vlla, in patients with hemorrhagic strokes
Countries: United States, Canada, Japan, Spain, the United Kingdom and Germany
Candidates: Patients ages 18 to 80 with spontaneous bleeding in the brain. The study won't apply to people who have a very large bleed, are deeply comatose or on blood thinners, among other exclusion criteria.
Participation: People can carry an "opt-out" card that could indicate their wish to decline participation in the study in the event of a stroke.
"For decades, decades, God knows how long, ischemic stroke has had the lion's share of advance and research and progress," said Dr. Babak Jahromi, vice chair of neurosurgery at Northwestern Medicine.
But a major clinical trial could hold the promise of a potentially lifesaving drug for people suffering hemorrhagic strokes.
Northwestern Medicine hospitals in Winfield and Chicago plan to take part in a federally funded study of a medication aimed at slowing or even stopping bleeding in the brain.
Researchers at more than 100 hospitals across the United States and five other countries hope to enroll 860 patients in the clinical trial over 3½ years. In Illinois, the University of Chicago and Loyola University Medical Center in Maywood also are among the listed sites participating in the study.
"If the trial is successful and shows that the outcomes improve by a magnitude of difference, then this will be a landmark trial," said Dr. Harish Shownkeen, medical director of stroke and neurovascular medicine at Northwestern Medicine Central DuPage Hospital in Winfield.
Expected to start by late summer, the study will test whether the drug will decrease bleeding if it's given to eligible patients within a short window of opportunity: no more than two hours from the start of their hemorrhagic stroke.
The drug is called recombinant Factor VIIa, or rFVIIa. But the name hardly conveys the anticipation for the trial. Researchers who have spent their careers in search of the first effective treatment for the most severe type of stroke say the study is a chance to leave a legacy.
"This would be on par with catheter-based treatment for stroke or the first clot-busting drug for stroke," said Dr. Andrew Naidech, the trial's principal investigator at Northwestern Memorial Hospital in Chicago. "This would be a major advance in the care of stroke patients."
Hemorrhagic strokes account for about 20% of all strokes. High blood pressure and smoking are some of the leading causes.
"With hemorrhagic stroke, there is a degree of upfront initial destruction as the blood leaks from the blood vessel," Jahromi said. "It's akin to having a garden hose on snow. It melts the brain in its path and injures whatever it hits, often in an irreversible fashion."
The clot-busting drug has become the gold standard for opening a plugged vessel and restoring blood flow to the brain in certain ischemic stroke patients. But there's currently "no specific treatment for intracerebral hemorrhage approved by the U.S. Food and Drug Administration," Naidech said.
In specific cases, doctors rush patients into the operating room and work to repair a site of bleeding, Jahromi said.
"But that can be more of a time-consuming process, and not all hospitals have easy access to brain surgeons who can do that," he said.
The drug under study, however, can be administered intravenously and without requiring technical expertise, Jahromi said. It's designed to amplify the body's blood clotting mechanisms.
"If we give this drug intravenously, it will travel throughout the body, and wherever there is a coagulation cascade already occurring, this supercharges it," Jahromi said, "building on the body's own natural way of sealing off holes in leaky blood vessels."
Earlier studies of the drug were "near misses" for a host of reasons, Naidech said. Previous trials that had a window of four hours to deliver the medication have shown some, but inconsistent, benefits, he said.
"This trial has been designed specifically to implement the lessons learned from previous trials," Naidech said.
Mobile stroke unit
Sponsored by the National Institutes of Health, the trial is based on the premise that the patients most likely to benefit are those given the medication at the earliest possible time.
Central DuPage Hospital is uniquely positioned to meet those study parameters with its mobile stroke unit, a special ambulance that brings stroke care to patients rather than waiting for them to come to the emergency room.
The hospital launched the unit -- the first of its kind to roll out in the state -- in January 2017. A crew of nurses and paramedics is dispatched when a 911 caller suspects someone is having a stroke.
The hospital team puts patients in a CT scanner in the lead-lined ambulance to determine whether a blood clot or a ruptured blood vessel in the brain is causing the stroke.
The ambulance team makes a video call with a neurologist to discuss the results and then begins treatment depending on the type of stroke.
For people with hemorrhagic strokes, the crew can provide medication to lower blood pressure, and when patients arrive at the hospital, they may need surgery and often a ventilator, doctors say.
With the mobile stroke unit, the hope is that qualified patients could receive the study drug within just half an hour, Shownkeen said.
Central DuPage plans to outline new procedures to the state to run the trial via its mobile stroke unit.
Patients will be randomly assigned to receive either the study drug or a placebo. The trial will be a double-blind study, meaning neither the patient nor the treating clinician are told who's taking the actual drug.
Researchers say every attempt would be made to reach family and get consent before a patient's enrollment if stroke victims couldn't speak for themselves. But the trial also is expected to allow for a patient's enrollment even if they were unable to communicate or a family member or other representative was not readily available to give consent.
Federal regulations establish how and when a so-called exception from informed consent is used for emergency research.
"It's used in studies where there's imminent threat to life, a highly possible effective treatment and severe time constraints," Naidech said.
Before launching such a study, researchers are required to do community outreach. That's been a "big process" involving many surveys and presentations, Jahromi said.
Prior trials have shown a slightly higher risk of blood clots forming in the legs, Jahromi said. Potential risks also could include clots in the lung.
Participants would get another CT scan within 24 hours to measure the size of the hemorrhage, Shownkeen said in a virtual talk to chambers of commerce. The study team would follow up with participants in person at six months.
"We see this as the best chance for patients with the deadliest form of stroke to get a treatment that can save their life," Naidech said.