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Efficacy and Safety Study on bIAP

NCT01010724 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2009-11-10

No results posted yet for this study

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

Interventions

DRUG

bIAP

DRUG

Placebo

Sponsors & Collaborators

  • Alloksys Life Sciences B.V.

    collaborator INDUSTRY

  • Catharina Ziekenhuis Eindhoven

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Netherlands

Study Locations

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Entities

Drugs
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 NCT01010724 on ClinicalTrials.gov