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Northwestern Medicine Researching Treatment for Strokes Caused by Bleeding in the Brain

If a weakened blood vessel in the brain breaks and the bleeding accumulates in the brain, the consequences are devastating. Strokes caused by intracerebral hemorrhage are usually very severe with a death rate of over 40 percent* within one month. Northwestern Medicine is planning to participate in a multi-center study funded by the National Institutes of Health (NIH) researching an emergency treatment for patients with an acute hemorrhagic stroke.

The FASTEST trial*, an acronym for Recombinant Factor VIIa for Acute hemorrhagic Stroke Administered at Earliest Time, is expected to be conducted at Northwestern Memorial Hospital in Chicago and Northwestern Medicine Central DuPage Hospital in Winfield, Illinois.

Recombinant Factor Vlla (rfVlla) is a protein that our body naturally makes to stop bleeding at a site of injury to a blood vessel. The study will determine if providing more highly concentrated rFVlla intravenously within two hours of onset of symptoms improves outcomes in patients with bleeding in the brain.

“Previous studies of rfVlla have shown inconclusive results. Our goal is to determine if a subgroup of patients is most likely to benefit, especially when providing the treatment within two hours of symptoms,” said Babak S. Jahromi, MD, PhD, vice chair of neurosurgery at Northwestern Medicine. “Our team has been on the forefront of advancing stroke care by bringing clinical trials to our patients, and we are greatly enthusiastic about the potential for this important research to improve treatment for hemorrhagic stroke.”

Northwestern Medicine Central DuPage Hospital may have the unique opportunity to provide the treatment on the health system’s Mobile Stroke Unit, a specialized ambulance with a CT scanner and stroke-specific trained staff that can make a diagnosis and begin treatment in the field.

“For hemorrhagic stroke, we can provide medication to lower blood pressure and when the patient arrives at the hospital, surgery may be performed to relieve pressure. However, we don’t currently have a non-surgical treatment to emergently slow or stop the bleed,” said Harish Shownkeen, MD, medical director of stroke and neurovascular medicine at Northwestern Medicine Central DuPage Hospital. “This study medication can be easily administered intravenously with rapid onset of action. We are excited to potentially offer it on the Mobile Stroke Unit.”

Intracerebral hemorrhage accounts for more than 10-percent of the estimated 17 million strokes worldwide each year and is the deadliest type of stroke with a mortality rate of more than 40-percent.* Those that survive face potentially life-long complications with only 20-percent able to independently care for themselves after six months.

The FASTEST study will include adults from 18 through 80 years old with spontaneous bleeding in the brain who are randomized into two groups. One group will receive rFVlla intravenously over two minutes. The other group will receive a placebo with no active ingredient. Medical care otherwise will be identical for the two treatment groups including close management of blood pressure and care within an intensive care unit. The study team will follow participants for 180 days after enrollment to evaluate their outcome.

Because acute ICH is a life-threatening condition requiring immediate treatment, this trial uniquely allows eligible patients to participate even if they are unconscious or a family member or other representative is not readily available to provide consent. Every attempt will be made to locate family prior to enrollment to allow them to decide about the patient’s participation in the study.

100 sites around the world are expected to take part in the FASTEST trial. Northwestern Medicine Central DuPage Hospital would be one of only 15 hospitals with a Mobile Stroke Unit participating.

Northwestern Medicine is seeking public feedback about this research trial. Please visit the NIH FASTEST website* to learn more about the study and provide your anonymous opinions and feedback. Opt out wallet cards are available via this website.

You may also call the Central DuPage Hospital study coordinator at 630.938.2625 or the Northwestern Memorial Hospital study coordinator at 312.695.0482 for more information and/or to request an opt out card.