Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot Polysaccharide Hemostatic System
Sponsor: |
CryoLife, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAN7661 |
U.S. Govt. ID: |
NCT02359994 |
Contact: |
Lyn Goldsmith: 212-342-0261 / lg2240@cumc.columbia.edu |
The purpose of this research study is to determine if PerClot is safe and effective to stop bleeding during surgery. PerClot is a medical device in granule form made from the starch of a potato. The starch has been engineered in a way that the powder absorbs water and helps to form a clot. This kind of device is intended for use in surgical procedures when control of bleeding by conventional methods is not working. PerClot is left in your body after surgery. This research study will look at how safe and effective PerClot is compared to another topical hemostat which has been approved by the FDA and is used in the USA. If you agree to be in this study, you will be randomized by chance (like flipping a coin) into one of the two study groups. Half of the patients will get PerClot and will be in the treatment group. The other half of the patients will receive an FDA approved, standard topical hemostat and will be in the control group. You have a 50/50 chance of receiving either PerClot or the approved topical hemostat.
This study is closed
Investigator
Michael Argenziano, MD, FACS
Will you be undergoing either a cardiac or urological procedure? |
Yes |
No |