A randomised, double-blind, placebo-controlled study of Glypromate® in patients undergoing cardiopulmonary bypass surgery: Studying Neurons Using Glypromate® - second study

Completed

• Conditions: Cardiopulmonary bypass surgery; Circulatory System

• Registration Number: ISRCTN47685900
• Lead Sponsor: euren Pharmaceuticals Limited (New Zealand)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Scheduled for non-emergency CABG surgery and/or valve replacement/repair, with CPB
2. Willing to provide written informed consent
3. Able and agreeable to undergo all cognitive and Activities of Daily Living (ADL) testing (i.e. understands English, able to read, write, have sufficient motor dexterity and be available for follow-up visit at 4 - 6 weeks and 12 - 14 weeks post surgery)
4. Greater than or equal to 50 years old

Exclusion Criteria

1. Pre-operative mechanical assist device or intra-aortic balloon pump inserted for shock or low output syndrome
2. Women of child-bearing potential or breastfeeding women
3. History of or any current condition that in the Investigator's opinion would interfere with study participation or evaluation of results
4. Congenital heart disease with a risk of polycythaemia, circulatory problems, or need for a shunt
5. Renal insufficiency (serum creatinine greater than 180 umol/L [greater than 2 mg/dL])
6. Past or present bleeding disorder
7. History of organic brain syndrome
8. Currently receiving treatment for alcohol or drug abuse
9. Currently participating in another investigational drug or device study
10. Prior enrolment in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified