Several Emergency Medical Service (EMS) providers and the hospitals that they serve in Los Angeles County have been selected to participate in a study sponsored by Diffusion Pharmaceuticals Inc, of Charlottesville, VA, called the Pre-Hospital Administration of Stroke Therapy – Trans Sodium Crocetinate (PHAST-TSC) Trial. This Trial is testing whether the administration of an investigational chemical, trans sodium crocetinate, into a vein in the arm is helpful to patients at the first signs of a stroke.
If you are having symptoms of a stroke, meet the study criteria, and 911 is called, you may be enrolled in the PHAST-TSC Trial. The paramedics who respond to your call are trained to identify potential study patients by following very strict criteria. If you are having weakness of the arm or face, are within 2 hours of start of symptoms, and have no other obvious cause of your symptoms besides stroke, you may be eligible for the study.
If you are able to make decisions for yourself, and there is enough time to explain the study in the ambulance, you will be asked to read a study consent form, have any questions answered by a study doctor on video cell phone, and decide whether or not you would like to enroll in the study.
You may be unable to make a decision for yourself because the stroke has impaired your ability to use language or to think, or there might not be enough time to explain the study to you in the ambulance. If this happens, and the study doctor finds that you meet all study criteria, you may still be enrolled in the study. The study doctor will still try to determine your feelings about the study and will not enroll you if you seem to not want to participate.
Any community member who does not want to be included in this study can obtain a medical alert bracelet that indicates to paramedics he/she has chosen to opt out of the study. To obtain a bracelet, call Diffusion Pharmaceuticals Inc. at (434) 220-0718.
You will only be enrolled in the study if family, friends, coworkers or other individuals who know you are with you at the time. The study doctor will explain the study to them and give family an opportunity to decline your participation.
Please contact Anna Grace, RN, PHAST-TSC Project Manager at (434) 220-0718, Ext 116