Bradykinin Receptor Antagonism During Cardiopulmonary Bypass

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Cardiopulmonary BypassInflammationFibrinolysisSurgery
Interventions
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.

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.

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.

Trial Locations (2)

37212

TN Valley Healthcare System, Nashville

37232

Vanderbilt University, Nashville

All Listed Sponsors
lead

Vanderbilt University

OTHER

NCT00223704 - Bradykinin Receptor Antagonism During Cardiopulmonary Bypass | Biotech Hunter | Biotech Hunter