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Bradykinin Receptor Antagonism During Cardiopulmonary Bypass (BRAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mias Pretorius, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00223704
First received: September 19, 2005
Last updated: October 15, 2013
Last verified: October 2013
Results First Received: July 29, 2013  
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
Conditions: Cardiopulmonary Bypass
Inflammation
Fibrinolysis
Surgery
Interventions: Drug: HOE 140
Drug: Aminocaproic Acid
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled by the research nurse at the time of the preoperative evaluation for surgery. All patients provided written informed consent. The study period was from June 2007 until June 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One hundred and fifty patients consented to participate in the study. Of these patients, 13 were excluded,12 withdrew before randomization, 4 had their surgeries canceled, 3 had their surgery dates changed, and 3 patients did not proceed with the study for other reasons. The remaining 115 patients were randomly assigned to one of three groups.

Reporting Groups
  Description
Placebo Group 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.
Aminocaproic Acid Group 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.
HOE 140 Group 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.

Participant Flow:   Overall Study
    Placebo Group     Aminocaproic Acid Group     HOE 140 Group  
STARTED     38     37     40  
COMPLETED     38     37     40  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Group Placebo was normal saline
Aminocaproic Acid Group Aminocaproic acid is an antifibrinolytic drug
HOE 140 Group Bradykinin B2 receptor antagonist
Total Total of all reporting groups

Baseline Measures
    Placebo Group     Aminocaproic Acid Group     HOE 140 Group     Total  
Number of Participants  
[units: participants]
  38     37     40     115  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     25     23     24     72  
>=65 years     13     14     16     43  
Age  
[units: years]
Mean ± Standard Deviation
  60.1  ± 10.8     58.5  ± 12.0     61.0  ± 12.8     59.9  ± 11.8  
Gender  
[units: participants]
       
Female     12     18     18     48  
Male     26     19     22     67  
Region of Enrollment  
[units: participants]
       
United States     38     37     40     115  



  Outcome Measures
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1.  Primary:   Allogenic Blood Product Transfusion Risk   [ Time Frame: Patients were followed for the duration of hospital stay, an average of 6 days ]

2.  Secondary:   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 ]

3.  Secondary:   Units of Plasma Transfused During Hospitalization   [ Time Frame: Patients were followed for the duration of hospital stay, an average of 6 days ]

4.  Secondary:   Inflammatory Response as Measured by Interleukin-6   [ Time Frame: Patients were followed from the start of surgery until postoperative day 2 ]

5.  Secondary:   Fibrinolytic Response as Measured by D-dimer   [ Time Frame: Patients were followed from the start of surgery until postoperative day 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was conducted in a population that predominantly underwent valve-only surgery. We cannot exclude the possibility that our results may have been different if we studied only coronary artery bypass graft surgery patients.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mias Pretorius, Associate Professor of Anesthesiology and Clinical Pharmacology
Organization: Vanderbilt University
phone: 615-8757402
e-mail: mias.pretorius@vanderbilt.edu


Publications of Results:

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
Results First Received: July 29, 2013
Last Updated: October 15, 2013
Health Authority: United States: Food and Drug Administration