Q. What is a pivotal trial?
A. A pivotal trial is designed to generate data suitable for seeking regulatory approval of a medical product. The Euphrates Trial is operating under an IDE received from the CDRH division of the FDA.
Q. What is a trial protocol?
A. All clinical trials must be conducted according to strict scientific and ethical principles. Every clinical trial must have a protocol, or action plan that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary - including details such as the criteria for patient participation, the schedule of tests, procedures, and medications, and the length of the study.
Q. Is the trial currently enrolling patients?
A. Yes, the trial began to enrolling patients in June 2010 and is currently ongoing.
Q. Where is the trial is being conducted?
A. In hospitals throughout the U.S. and Canada. A complete list of sites, and more information on the trial can be found at www.clinicaltrials.gov
Q. What is the trial endpoint?
A. The primary endpoint is 28 day mortality.
Q. What is the control group?
A. Subjects randomized to control receive standard of care as per following the basic tenets of the surviving sepsis guidelines.
Q. What is the intervention?
A. Toraymyxin hemoperfusion adsorption column, run at 100 ml/min (80-120 ml/min) x 2 hours, twice in a 24 hour period.
Q. Who can I contact if I have questions on the trial?
A. Debra Foster, Vice President, Clinical Development: email@example.com
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