Overview

Efficacy and Safety Study on bIAP

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Collaborator:
Alloksys Life Sciences B.V.