Status:
UNKNOWN
Effects of Omega-3 Fatty Acids on Outcome After Major Liver Resection
Lead Sponsor:
University of Zurich
Conditions:
Major Liver Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To study the efficacy and safety of intravenous Omegaven™ (vs. Placebo) in reducing postoperative morbidity and mortality after major liver resection.
Detailed Description
With two single doses of Omegaven (pre- and postoperatively) we aim to reduce postoperative complications measured by the CCI (Comprehensive Complication Index) and the Clavien Dindo classification of...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT01884948
Start Date
July 1 2013
End Date
March 1 2016
Last Update
June 4 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Zurich, Visceral and Transplantation Surgery
Zurich, Canton of Zurich, Switzerland, 8091