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

NCT01144611 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2016-09-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Aix Scientifics

    collaborator INDUSTRY

  • Alloksys Life Sciences B.V.

    lead INDUSTRY

Principal Investigators

  • M.Erwin S.H. Tan, Prof.Dr.med. · Catharina Ziekenhuis, Dept. CardioThoracic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01144611 on ClinicalTrials.gov