Trial FAQ
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. 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 goup? |
A. |
Subjects randomized to control receive standard of care as per following the basic tenets of the 2008 surviving sepsis guidelines. |
Q. |
What is the intervention? |
A. |
Toraymyxin hemoperfusion adsorption column, run at 100ml/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 |