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Table 1 Study synopsis

From: “A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven™) on outcome after major liver resection”

Sponsor investigator Prof. Pierre-Alain Clavien, MD PhD
Study product Omegaven™, 100 ml intravenously administered at the evening before and during liver resection
Primary endpoint Postoperative morbidity and mortality determined by the Clavien- Dindo classification of surgical complications and the Comperative Complication Index (CCI) 1 month after hospital discharge.
Secondary endpoints Main center:
Serum samples: postoperative peak AST and ALT, fatty acids and n3 PUVA concentration, inflammatory markers
Liver biopsy: histology (necrosis, apoptosis), inflammatory markers, hepatic fatty acid and n3 PUVA content
Main center and external centers:
Duration of hospitalization and ICU stay
Hematology: hemoglobin, hematocrit, leukocytes, platelets, INR
Chemistry: triglycerides, bilirubin, AST, ALT, ALKP, creatinin, CRP
Methodology Randomized, double-blind, placebo controlled
Clinical phase Phase III (new indication for Omegaven™)
Study duration 3 years (start: July 2013)
Study centers Multi-center (Zurich, Bucharest, Moscow)
Number of subjects 258 patients
Main inclusion criteria Adult (more than 18 years) requiring liver resection of at least 1 segment or multiple wedge resections (≥3); no coagulopathy (INR ≤ 1.2, platelets ≥ 150,000 × 103/μl)
Main exclusion criteria Liver resections <1 segment, wedge resections (<3); coagulopathy (INR > 1.2, platelets < 150,000 × 103/μl); hypertriglyceridemia (>5.0 mmol/l); liver cirrhosis; severe renal failure (estimated GFR < 30 ml/min/1.73 m2); pregnancy. ID: NCT01884948