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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.

ClinicalTrial.gov

ID: NCT01884948