NCT01010724

Efficacy and Safety Study on bIAP

A Randomized, Double-Blind, Placebo Controlled Study of Biap, an Endotoxin Detoxificating Moiety, in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Catharina Ziekenhuis Eindhoven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Endotoxin-mediated Complications From Cardiopulmonary Bypass Surgery

Interventions

Type	Name	Description
DRUG	bIAP
DRUG	Placebo

Timeline

• First posted: 2009-11-10
• Last updated: 2009-11-10

Locations

1 site across 1 country: Netherlands