A global clinical trial is underway to investigate the potential of Recombinant Factor 7A in halting brain bleeds following a stroke. Led by neurologist Joseph Broderick, the study aims to improve outcomes for patients suffering from hemorrhagic strokes, a condition where bleeding occurs in the brain. The trial is enrolling over 800 patients across 100 cities in the U.S., Japan, Canada, and Europe.
Targeting Early Intervention
The study focuses on administering Recombinant Factor 7A within the first few hours after stroke onset, a critical window when the drug is believed to have the greatest benefit. "We looked at people who were within the very early time windows within the first couple hours after onset, that's when the drug seemed to have its greatest benefit," said Dr. Broderick.
Expediting Treatment with Mobile Stroke Units
To overcome time limitations, the trial is employing mobile stroke units equipped with brain imaging capabilities. These units allow for on-the-spot diagnosis and drug administration en route to the hospital. The goal is to treat patients within two hours of stroke onset. "We wanted to make sure we could treat people within two hours," Broderick stated.
Exception from Informed Consent
Given the urgency of stroke treatment, the FDA has granted permission for a practice known as "exception from informed consent." This allows medical personnel to administer the treatment quickly, even without the immediate consent of the patient or family member, ensuring that eligible patients receive the drug within the critical time window.
Recombinant Factor 7A: A Hemophilia Drug with New Potential
Recombinant Factor 7A, traditionally used to help blood clot in hemophiliacs, is being repurposed for this study. The drug's ability to stop bleeding makes it a potential candidate for halting brain bleeds after a stroke, which could significantly improve patient outcomes by preventing further brain damage.
Addressing a Critical Need
While TPA has been successful in treating ischemic strokes, there remains a need for effective treatments for hemorrhagic strokes. This trial represents a significant step forward in addressing this unmet medical need. "But there's a good number of them. They're going to continue to grow. So, if we can stop the growth in its tracks, we can have an opportunity to improve the outcome," Broderick said.
