NCT01144611

Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery

A Randomized, Double-blind, Placebo-controlled Phase IIIa Study on bIAP, an Anti-inflammatory Moiety, in Patients Undergoing Combined Aortic Valve Replacement and Coronary Artery Bypass Grafting

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Alloksys Life Sciences B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical responses and thereby preserving organ functions in patients undergoing invasive cardiac surgery: combined aortic valve replacement and coronary artery bypass grafting.

Conditions

• Inflammation

Interventions

Type	Name	Description
DRUG	bIAP bolus and 8h infusion	intravenous as a bolus of bIAP (bovine intestinal alkaline phosphatase, 1000 IU) just prior to surgery followed by a 40 IU/kg bIAP infusion during the first 8 hours post surgery.
DRUG	placebo bolus and 8h infusion	intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery.

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-06-15
• Last updated: 2016-09-20

Locations

1 site across 1 country: Netherlands