VolulyteTM in Cardiac Surgery

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fresenius Kabi
• Treatments: Hydroxyethyl Starch Derivatives; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• male or female adult patients

• undergoing primary elective cardiac surgery applying extracorporeal circulation

• signed written informed consent

Exclusion Criteria:

• known contraindication against scheduled medication

• pre-operative acute normovolaemic haemodilution or preoperative autologous blood donation

• planned systemic hypothermia (body temperature < 30°C)

• expected time on ECC ≥ 2 hours