Bradykinin Receptor Antagonism During Cardiopulmonary Bypass (BRAC)
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ClinicalTrials.gov Identifier: NCT00223704 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Results First Posted : October 11, 2013
Last Update Posted : November 25, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiopulmonary Bypass Inflammation Fibrinolysis Surgery | Drug: HOE 140 Drug: Aminocaproic Acid Drug: Placebo | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Bradykinin Receptor Antagonism During Cardiopulmonary Bypass |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: HOE 140
Bradykinin receptor antagonist
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Drug: HOE 140
HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
Other Name: Icatibant |
Active Comparator: Aminocaproic Acid
Antifibrinolytic
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Drug: Aminocaproic Acid
Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
Other Names:
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Placebo Comparator: Placebo
Placebo
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Drug: Placebo
Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
Other Name: Placebo/Normal Saline |
- Allogenic Blood Product Transfusion Risk [ Time Frame: Patients were followed for the duration of hospital stay, an average of 6 days ]Blood product transfusion during hospitalization that included packed red blood cells, plasma, platelets and cryoprecipitate.
- Units of Packed Red Blood Cells Transfused During Hospitalization [ Time Frame: Patients were followed for the duration of hospital stay, an average of 6 days ]Units of Packed Red Blood Cells Transfused
- Units of Plasma Transfused During Hospitalization [ Time Frame: Patients were followed for the duration of hospital stay, an average of 6 days ]Units of plasma transfused
- Inflammatory Response as Measured by Interleukin-6 [ Time Frame: Patients were followed from the start of surgery until postoperative day 2 ]Interleukin-6 was measured at baseline, post-bypass and on postoperative day 1 and 2.
- Fibrinolytic Response as Measured by D-dimer [ Time Frame: Patients were followed from the start of surgery until postoperative day 1 ]D-dimer concentrations were measured at baseline, 30min and 60min of bypass, post-bypass and postoperative day 1

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223704
United States, Tennessee | |
TN Valley Healthcare System | |
Nashville, Tennessee, United States, 37212 | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Mias Pretorius, MBChB | Vanderbilt University |
Responsible Party: | Mias Pretorius, Associate Professor, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00223704 |
Other Study ID Numbers: |
IRB #051171 HL085740-02 |
First Posted: | September 22, 2005 Key Record Dates |
Results First Posted: | October 11, 2013 |
Last Update Posted: | November 25, 2013 |
Last Verified: | October 2013 |
Coronary Artery Bypass Blood Transfusion Bradykinin Receptor Antagonism Anti-Inflammatory Agents Antifibrinolytic Agents |
Inflammation Pathologic Processes Icatibant Aminocaproic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Bradykinin B2 Receptor Antagonists Bradykinin Receptor Antagonists Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors |