Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass
This study has been terminated.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00316212
First received: April 18, 2006
Last updated: August 9, 2006
Last verified: August 2006
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Purpose
The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion that are well-tolerated and which reduce postoperative bleeding and blood product transfusion.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Disease |
Drug: INS50589 Intravenous Infusion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel Group Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Graft Surgery Involving Cardiopulmonary Bypass |
Resource links provided by NLM:
Further study details as provided by Merck:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Are scheduled for primary CABG by median sternotomy involving cardiopulmonary bypass
- Willing to receive allogeneic blood product transfusions during and after surgery
Exclusion Criteria:
- Have had previous cardiac surgery
- Have had previous median sternotomy
- Have tendency for bleeding or family history of bleeding
- Have an abnormally low platelet count
- Have received certain anticoagulant or antiplatelet medications within a specified time period prior to the scheduled CABG surgery
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316212
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Hide Study LocationsLocations
| United States, Alabama | |
| Baptist Medical Center Princeton | |
| Birmingham, Alabama, United States, 35211 | |
| Cardiology, P.C. | |
| Birmingham, Alabama, United States, 35211 | |
| United States, California | |
| Sharp Memorial Hospital | |
| San Diego, California, United States, 92123 | |
| United States, Illinois | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794-9638 | |
| Memorial Medical Center | |
| Springfield, Illinois, United States, 62702 | |
| St. John's Hospital | |
| Springfield, Illinois, United States, 62769 | |
| United States, Indiana | |
| Lutheran Hospital of Indiana | |
| Fort Wayne, Indiana, United States, 46804 | |
| United States, Kentucky | |
| University of Kentucky, Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536 | |
| Veterans Affairs Medical Center | |
| Lexington, Kentucky, United States, 40506 | |
| United States, Michigan | |
| Covenant Medical Center | |
| Saginaw, Michigan, United States, 48602 | |
| St. Mary's of Michigan | |
| Saginaw, Michigan, United States, 48601 | |
| United States, New York | |
| Viahealth Rochester General Hospital | |
| Rochester, New York, United States, 14621 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| The Brody School of Medicine, East Carolina University | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| Good Samaritan Hospital | |
| Cincinnati, Ohio, United States, 45220 | |
| Cardiac, Vascular, & Thoracic Surgeons, Inc. | |
| Cincinnati, Ohio, United States, 45209 | |
| Bethesda North Hospital | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Oklahoma | |
| Oklahoma Cardiovascular Associates | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Oklahoma Cardiovascular Research Group | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Oklahoma Heart Hospital | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Tennessee | |
| Jackson Madison County General Hospital | |
| Jackson, Tennessee, United States, 38301 | |
| CardioThoracic Surgery Center, PLC | |
| Jackson, Tennessee, United States, 38301 | |
| Centennial Medical Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Winchester Medical Center | |
| Winchester, Virginia, United States, 22601 | |
| United States, Washington | |
| FHS Research Center, St. Joseph Medical Center | |
| Tacoma, Washington, United States, 98405 | |
| Northwest Cardiovascular Associates | |
| Tacoma, Washington, United States, 98405 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00316212 History of Changes |
| Other Study ID Numbers: | 025-102 |
| Study First Received: | April 18, 2006 |
| Last Updated: | August 9, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass |
Additional relevant MeSH terms:
|
Coronary Disease Coronary Artery Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 23, 2013