Randomized, Multicenter, Placebo-Controlled Double-Blind, Parallel Group Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Graft Surgery Involving Cardiopulmonary Bypass
| Purpose of trial: |
The purpose of this study is to find dose(s) of INS50589 that are well tolerated and that reduce bleeding and the need for blood to be given to the patient during and after heart surgery |
| Protocol Summary: |
This is an investigational drug study that is being conducted to see if the drug (INS50589) reduces bleeding and the need for blood to be given during and after surgery. This study is a randomized study and patients will have a 3 out of 4 chance of getting the drug. Of every four patients, three will get the drug and one will get a sterile salt solution. The drug or placebo will start in surgery and will go for up to 8 hours. There will be 40 patients in each group. This medication will be given through a vein. There will be EKGs, blood tests and urine tests done as per protocol. Patients will be seen before surgery, after surgery and 30 days following surgery |
| Sponsoring Department: | Surgery - Division of Cardiothoracic Surgery |
| Sponsoring Company: | Inspire Pharmaceuticals, Inc. |
| Investigators: | Stephen R. Hazelrigg, MD, Jacquelyn Quin, MD, William Pyle, MD, Carl Arentzen, MD, William Stevens, MD, Theresa Boley, RN, MSN, APN/FNP |
| Number of other sites in trial: | SIU School of Medicine; Memorial Medical Center, St. John's Hospital |
| Basic Eligibility Criteria: | Having Coronary Artery Bypass Grafting for the first time with a heart-lung bypass machine, giving informed consent |
| Age: | 18 years of age or older to 75 years of age |
| Contact Person: | Contact Person: Theresa Boley, RN, MSN, APN/FNP Contact Phone: 217-545-5000 Contact Email: tboley@siumed.edu |