Efficacy and Safety Study on bIAP (APPIRED)
The study drug bIAP, or matching placebo, will be administered as a bolus of 1000 Units bIAP or matching placebo prior to anaesthesia (T = -15 minutes), directly followed by intravenous continuous infusion of about 5.6 units per kg bodyweight/hr at pump rate 4 ml/hr for approximately 36 hrs (total 200 IU/kg/36 hrs) into each of a total of 50 patients scheduled for coronary artery bypass graft surgery (CABG). Risk of surgical complications and mortality due to co-morbid conditions will be collected and the EuroSCORE will be used to screen patients prior to surgery.
Coronary Artery Disease
Endotoxin-mediated Complications From Cardiopulmonary Bypass Surgery
|Official Title:||A Randomized, Double-Blind, Placebo Controlled Study of Biap, an Endotoxin Detoxificating Moiety, in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass|
- To determine the efficacy and safety of bIAP as a prophylaxis against endotoxin-mediated complications from cardiopulmonary bypass surgery
Dosage 200 IU bIAP/kg: 1000 IU prior to anaesthesia administered as a bolus followed by intravenous continuous infusion of 5,6 IU/kg/hr for approximately 36 hours.
|Placebo Comparator: Placebo||Drug: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010724
|Catharina hospital, dept. of Cardiothoracic Surgery|
|Eindhoven, Netherlands, 5623EJ|