DALTEPARIN SODIUM for Liver resection | Venous thromboembolism

Inclusion criteria

• {"criterion_text":"-All patients undergoing liver resection"}

Exclusion criteria

• {"criterion_text":"-Patient on anti-coagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during last month pre-surgery."}
• {"criterion_text":"-Emergency operation (e.g., for trauma or infection)."}
• {"criterion_text":"-Age < 18 years"}
• {"criterion_text":"-Allergy or other contraindication to planned low-molecular weight heparin."}
• {"criterion_text":"-Inability to give written informed consent."}
• {"criterion_text":"-Liver resection not performed (removed from analyses after randomization)."}

Primary endpoints

• {"endpoint_text":"-Venous thromboembolisms, number of patients, within 30 days from liver resection.","definition_or_measurement_approach":"Number of patients with venous thromboembolisms occurring within 30 days from liver resection (count of patients with VTE within 30 days)."}

Secondary endpoints

• {"endpoint_text":"-1) Posthepatectomy haemorrhage, any grade in ISGLS classification, number of patients, within 30 days from liver resection","definition_or_measurement_approach":"Number of patients with posthepatectomy haemorrhage within 30 days, graded according to ISGLS classification."}
• {"endpoint_text":"-2) Comprehensive Complication Index – score, within 30 days from liver resection","definition_or_measurement_approach":"Comprehensive Complication Index (CCI) score calculated for complications within 30 days after liver resection."}
• {"endpoint_text":"-3) Length of postoperative hospital stay, days","definition_or_measurement_approach":"Length of postoperative hospital stay measured in days."}
• {"endpoint_text":"-4) Total amount of transfused red blood cells, units, during and within 30 days from liver resection","definition_or_measurement_approach":"Total number of units of transfused red blood cells given during the index admission and within 30 days after liver resection."}

Norway

Earliest CTIS Part Ii Submission Date

13-12-2024

Latest Decision Or Authorization Date

19-12-2024

Processing Time Days

6

Number Of Sites

2

Number Of Participants

500

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway