Researchers to Test Groundbreaking Treatment for Intracerebral Hemorrhage-Type Strokes
Clot-busting drugs can be used to treat patients with ischemic strokes, but there are no good pharmacological alternatives for patients with intracerebral hemorrhages (ICH). This is a concerning treatment gap because ICH-type stroke outcomes can be dire.
However, the creators of a new trial are testing whether a drug already used in other applications can offer benefits to patients with ICH strokes. Recombinant factor VIIa (rFVIIa) is a protein the body makes to stop bleeding related to blood vessel injuries. Researchers hypothesize it might improve outcomes for ICH patients. If the results are positive, frontline providers might be able to add an important therapeutic tool to help ICH-type stroke patients.
The authors of rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) are looking for sites that want to participate in this potentially groundbreaking research.
“There is no scientifically proven treatment for acute ICH, the most devastating of all stroke subtypes,” explains Joseph Broderick, MD, principal investigator and director of the University of Cincinnati Gardner Neuroscience Institute in Cincinnati. “Two potential approaches include stopping the bleeding or removing blood surgically. Surgical removal has not been demonstrated to clearly change outcomes, at least in the way it has been done so thus far.”
Broderick notes to be successful, rFVIIa will have to be administered to patients quickly, within two hours of brain bleeding onset. With this narrow treatment window in mind, Broderick and colleagues are aiming to compare ICH patients who receive rFVIIa to ICH patients who receive placebo.
To pull this off, investigators will use exception from informed consent (EFIC). “If we have a legal representative available, we get consent. If we can’t find someone initially, we can enroll the patient and pursue consent vigorously as soon as someone is identified [who can provide consent],” Broderick explains. (More background from the FDA on EFIC is available online at this link.)
This is the first trial that will take advantage of mobile stroke units (MSU) to accelerate the administration of a new treatment, according to James Grotta, MD, FAAN, another FASTEST co-principal investigator. “There will be 15 mobile stroke units that will be incorporated into this trial in both the U.S. and Germany,” says Grotta, director of stroke research at the Clinical Institute for Research and Innovation at Memorial Hermann-Texas Medical Center.
Grotta notes EDs will serve as FASTEST sites, too. “So long as the patient can be treated within two hours, it doesn’t matter whether they are in an MSU or the ED,” adds Grotta, founder and director of the Houston Mobile Stroke Unit Consortium.
There are risks to consider when using rFVIIa. Mainly, these concern the medication’s actions at the site of any vessel injury in any part of the body. For instance, Broderick notes cardiac arteries could have damaged vessel walls.
At this point, Broderick stresses rFVIIa should not be used for ICH patients except as part of a clinical trial. “Until we know it clearly benefits patients, it should not be used in clinical practice,” he says.
FASTEST investigators are enrolling patients, although the COVID-19 pandemic has slowed the process significantly. At press time, four study sites were up and running, with the goal of engaging 100 sites globally.
“They should be sites that have a good volume of ICH, have research experience involving acute stroke patients, and sites that are committed to very rapid treatment of stroke patients,” Broderick says. (Editor’s Note: For more information about FASTEST, please visit this link.)
Clot-busting drugs can be used to treat patients with ischemic strokes, but there are no good pharmacological alternatives for patients with intracerebral hemorrhages (ICH). This is a concerning treatment gap because ICH-type stroke outcomes can be dire. The creators of a new trial are testing whether a drug already used in other applications can offer benefits to patients with ICH strokes.
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