NCT01418521

Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) After Cardiac Surgery

Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) Versus Albumin Solution for Volume Replacement in Patients After Cardiac Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in terms of safety and effectiveness as the commonly used albumin based solution for volume replacement after the surgery.

Conditions

• Elective Cardiac Surgery

Interventions

Type	Name	Description
DRUG	Balanced hydroxyethyl starch solution	Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.
DRUG	Ringer- albumin	Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2011-08-17
• Last updated: 2011-08-17

Locations

1 site across 1 country: Israel