Effects of Omega-3 Fatty Acids on Outcome After Major Liver Resection

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the efficacy and safety of intravenous Omegaven™ (vs. Placebo) in reducing postoperative morbidity and mortality after major liver resection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich

Criteria

Inclusion criteria:

• Requiring liver resection of at least 1 segment or multiple wedge resections (=3)

• > 18 years of age

• No coagulopathy (INR < 1.2, platelets >150'000 x10E3/µl)

• Understands local language

Exclusion criteria:

• Liver resections <1 segment

• Wedge resections (<3)

• Liver cirrhosis

• Coagulopathy (INR > 1.2, platelets < 150'000 x10E3/µl)

• Hypertriglyceridemia (> 5.0 mmol/l)

• Hypersensitivity or allergy to Omegaven™ or any fish oil or lipid emulsions

• Known allergy to egg protein

• Pregnancy

• Nursing women

• Renal failure(estimated GFR < 30 ml/min/1.73m2)

• Medication impairing platelets aggregation

• Cannot understand local language