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| Sponsor: | Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00223704 |
Purpose
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 products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Arteriosclerosis |
Drug: HOE 140 Drug: Aminocaproic Acid Drug: Placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Bradykinin Receptor Antagonism During Cardiopulmonary Bypass |
| Estimated Enrollment: | 183 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HOE 140
Bradykinin receptor antagonist
|
Drug: HOE 140
Bradykinin receptor antagonist administered prior to CPB
Other Name: Icatibant
|
|
Active Comparator: Aminocaproic Acid
Antifibrinolytic
|
Drug: Aminocaproic Acid
Amionocaproic acid administered prior to CPB
Other Name: Amicar
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo
Other Name: Placebo/Normal Saline
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
Contacts and Locations| Contact: Patricia Wright, RN | (615) 343 0908 | patricia.wright@vanderbilt.edu |
| Contact: Mias Pretorius, MBChB, MSc | (615) 343 0665 | mias.pretorius@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Patricia Wright, RN 615-343-0908 patricia.wright@vanderbilt.edu | |
| Principal Investigator: Mias Pretorius, MBChB | |
| TN Valley Healthcare System | Recruiting |
| Nashville, Tennessee, United States, 37212 | |
| Contact: Patricia Wright, RN 615-343-0908 patricia.wright@Vanderbilt.edu | |
| Principal Investigator: Mias Pretorius, MBChB | |
| Principal Investigator: | Mias Pretorius, MBChB | Vanderbilt University |
More Information
| Responsible Party: | Mias Pretorius, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00223704 History of Changes |
| Other Study ID Numbers: | IRB #051171, HL085740-02 |
| Study First Received: | September 19, 2005 |
| Last Updated: | July 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Coronary Artery Bypass Blood Transfusion Bradykinin Receptor Antagonism Anti-Inflammatory Agents Antifibrinolytic Agents |
|
Arteriosclerosis Coronary Artery Disease Myocardial Ischemia Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Coronary Disease Heart Diseases 6-Aminocaproic Acid Antifibrinolytic Agents Icatibant Anti-Inflammatory Agents Bradykinin Kininogens Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Vasodilator Agents Cardiovascular Agents Cysteine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |