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Bradykinin Receptor Antagonism During Cardiopulmonary Bypass- Specific Aim 3 (BRAC)
This study is currently recruiting participants.
Verified by Vanderbilt University, April 2009
First Received: September 19, 2005   Last Updated: April 10, 2009   History of Changes
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: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Bradykinin Receptor Antagonism During Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Allogenic blood product transfusion risk. [ Time Frame: Hospitilization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of transfusions in patients exposed to blood products [ Time Frame: Hospitilization ] [ Designated as safety issue: No ]
  • Blood loss [ Time Frame: Hospitilization ] [ Designated as safety issue: No ]
  • Renal dysfunction [ Time Frame: Hospitilization ] [ Designated as safety issue: Yes ]
  • Dysrhythmias [ Time Frame: Hospitilization ] [ Designated as safety issue: Yes ]
  • Prolonged intubation [ Time Frame: Hospitilization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 183
Study Start Date: May 2006
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HOE 140: Experimental
Bradykinin receptor antagonist
Drug: HOE 140
Bradykinin receptor antagonist administered prior to CPB
Aminocaproic Acid: Active Comparator
Antifibrinolytic
Drug: Aminocaproic Acid
Amionocaproic acid administered prior to CPB
Placebo: Placebo Comparator
Placebo
Drug: Placebo
Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects, 18 to 80 years of age, scheduled for elective CABG requiring CPB
  2. 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 Criteria:

  1. Evidence of coagulopathy (INR greater than 1.7 without warfarin therapy)
  2. Preoperative hematocrit less than 30%
  3. Preoperative platelet count less than 100X109ml-1
  4. GPIIb/IIIa antagonist within 48 hours of surgery
  5. Emergency surgery
  6. Impaired renal function (serum creatinine >1.6 mg/dl)
  7. Pregnancy
  8. Breast-feeding
  9. 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
  10. History of alcohol or drug abuse
  11. Treatment with any investigational drug in the 1 month preceding the study
  12. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
  13. Inability to comply with the protocol, e.g. uncooperative attitude and unlikelihood of completing the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223704

Contacts
Contact: Patricia Wright, RN (615) 343 0908 patricia.wright@vanderbilt.edu
Contact: Mias Pretorius, MBChB, MSc (615) 343 0665 mias.pretorius@vanderbilt.edu

Locations
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            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Mias Pretorius, MBChB Vanderbilt University
  More Information

No publications provided

Responsible Party: Vanderbilt University ( Mias Pretorius )
Study ID Numbers: IRB #051171, HL085740-02
Study First Received: September 19, 2005
Last Updated: April 10, 2009
ClinicalTrials.gov Identifier: NCT00223704     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Coronary Artery Bypass
Blood Transfusion
Bradykinin Receptor Antagonism
Anti-Inflammatory Agents
Antifibrinolytic Agents

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Anti-Inflammatory Agents
Vasodilator Agents
Heart Diseases
Coagulants
Molecular Mechanisms of Pharmacological Action
Bradykinin
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Cardiovascular Agents
Arteriosclerosis
6-Aminocaproic Acid
Hemostatics
Pharmacologic Actions
Coronary Disease
Fibrin Modulating Agents
Antifibrinolytic Agents
Therapeutic Uses
Cardiovascular Diseases
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 09, 2009