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Trial Testing Paramedic-Delivered Stroke Drug

Ambulance

(Jelle Seubring, Flickr)

1 July 2019. A clinical trial is getting underway testing a treatment for stroke delivered to patients by emergency medical technicians on the way to the hospital. The study is sponsored by Diffusion Pharmaceuticals in Charlottesville, Virginia, developer of trans-sodium crocetinate or TSC a small-molecule or low molecular weight drug, for patients suspected of suffering a stroke.

TSC is designed to move more oxygen to tissue and cells deprived of oxygen, a state known as hypoxia. This oxygen-deprived condition says the company, is found in heart disease and cancer, as well as stroke, and Diffusion is developing formulations of TSC for these disorders. The chemistry in TSC is based on crocetin, a natural substance found in the spice saffron, used as an herbal remedy in ancient Chinese and Arabian cultures, and studied today for its anti-cancer properties.

In stroke patients, the lack of oxygen to the brain in the vast majority of cases (85%) is a result of blood clots, while most other strokes are caused by blood vessel leakage in the brain. Nearly 800,000 people in the U.S. have a stroke each year, with paralysis and weakness in the limbs among the results. Recovery, often in rehabilitation clinics, can take months or years of continuous exercises.

Early diagnosis and treatment for stroke, within the first three hours, is vitally important to prevent long-term disability. The mid-stage clinical trial is enrolling 160 patients calling 9-1-1 in Charlottesville and surrounding counties, with ambulances sent to the patients for emergency treatment and transport to the hospital. Emergency medical responders will be trained if needed in recognition of stroke systems and providing cardiac life support.

Upon arrival at the patient’s site, emergency medical technicians will call University of Virginia medical center to confirm their initial diagnosis of a stroke and ask patients or family members if they want to take part in the trial. Only those patients giving an affirmative response will then be enrolled. Among those enrolled, participants will be randomly assigned to receive a single injection of TSC or a salt-water placebo. Patients will otherwise receive the standard care for stroke, and at the hospital they or family members will be asked for consent to participate further in the trial.

Patients choosing to participate will be monitored 1, 2, and 4 days following arrival at the hospital, then after 30 and 90 days. Researchers led by University of Virginia neurologist Andrew Southerland is looking mainly at overall disability levels of patients after 90 days on a scale ranging from no disability to severe disabled conditions, such as bed-ridden and incontinent, or death. The study team is also tracking several other measures of disability, neurological deficit, functional independence, and quality of life.

University of Virginia medical center is meeting with people in Charlottesville and surrounding communities about the clinical trial, and allowing residents to opt-out of the study in advance. “Because of the need enroll patients in the ambulance prior to hospital arrival, patients may not be able to provide full informed consent,” says Southerland in a medical center statement. “Therefore, it is very important that the community know about this. Anyone who does not want to participate may opt out, but we also are asking for public feedback about the trial.”

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