Status:
COMPLETED
Bradykinin Receptor Antagonism During Cardiopulmonary Bypass
Lead Sponsor:
Vanderbilt University
Conditions:
Cardiopulmonary Bypass
Inflammation
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood pr...
Detailed Description
Morbidity of cardiopulmonary bypass. Each year more than a million patients worldwide undergo cardiac surgery. Nearly all cardiac surgeries are performed on unbeating hearts supported by CPB. Although...
Eligibility Criteria
Inclusion
- Subjects, 18 to 80 years of age, scheduled for elective CABG requiring CPB
- For female subjects, the following conditions must be met:
- postmenopausal for at least 1 year, or status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and willing to undergo urine beta-hcg testing prior to drug treatment and on every study day
Exclusion
- Evidence of coagulopathy (INR greater than 1.7 without warfarin therapy)
- Preoperative hematocrit less than 30%
- Preoperative platelet count less than 100X109ml-1
- GPIIb/IIIa antagonist within 48 hours of surgery
- Emergency surgery
- Impaired renal function (serum creatinine \>1.6 mg/dl)
- Pregnancy
- Breast-feeding
- Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
- History of alcohol or drug abuse
- Treatment with any investigational drug in the 1 month preceding the study
- Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
- Inability to comply with the protocol, e.g. uncooperative attitude and unlikelihood of completing the study
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00223704
Start Date
May 1 2006
End Date
June 1 2012
Last Update
November 25 2013
Active Locations (2)
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1
TN Valley Healthcare System
Nashville, Tennessee, United States, 37212
2
Vanderbilt University
Nashville, Tennessee, United States, 37232