Primary and Metastatic Liver Cancer
Conditions
Interventions
Early Anticoagulation Group:Patients should begin subcutaneous injections of low-molecular-weight heparin calcium (nadroparin calcium injection) within 24 hours after surgery, at a fixed dose of 4,100
Delayed Anticoagulation Group:Patients should begin subcutaneous injections of low-molecular-weight heparin calcium (nadroparin calcium injection) within 24–72 hours after surgery, at a fixed dose of
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years, male or non-pregnant female; 2.Histologically, cytologically, or clinically/radiologically confirmed primary or metastatic malignant liver tumor, including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, combined hepatocellular–cholangiocarcinoma, colorectal liver metastases, or liver metastases from other solid tumors, with planned curative-intent or cytoreductive liver tumor resection. 3.Eligible and scheduled to undergo liver tumor resection. 4.Able and willing to comply with all study procedures, as assessed by the investigator. 5.Written informed consent provided before enrollment. 6.Child–Pugh class A within 14 days before enrollment, or liver function considered adequate for the planned extent of resection. 7.Adequate hematologic and organ function, including hemoglobin >=85 g/L, creatinine clearance =30 mL/min, and total bilirubin <=2–3 times the upper limit of normal, as assessed by the investigator. 8.For patients with active hepatitis B or C virus infection, the investigator must determine that liver tumor resection and prophylactic anticoagulation are clinically acceptable. Antiviral therapy should preferably be initiated at least 7 days before enrollment and continued during the study. 9.Women of childbearing potential must have a negative pregnancy test before treatment. Women of childbearing potential and sexually active men with partners of childbearing potential must agree to use effective contraception during treatment and for 1 month after the final study dose.
Exclusion criteria
Exclusion criteria: 1.Pre-existing or ongoing therapeutic anticoagulation, including vitamin K antagonists, direct oral anticoagulants, unfractionated heparin, or other anticoagulants that cannot be discontinued or appropriately managed before surgery. 2.Active bleeding; a history of clinically significant bleeding; a diagnosed bleeding disorder or coagulopathy; or any condition considered by the investigator to confer a substantial bleeding risk. 3.Platelet count <100 × 10?/L. 4.History of heparin-induced thrombocytopenia or known hypersensitivity to heparin or nadroparin calcium. 5.Any contraindication to nadroparin calcium or other anticoagulant therapy. 6.Untreated or inadequately controlled esophageal and/or gastric varices associated with active bleeding or a high risk of bleeding. 7.Peptic ulcer diagnosed within 6 weeks before enrollment. 8.Severe or uncontrolled hypertension. 9.Severe hepatic impairment, including prothrombin activity <60%, clinically significant coagulopathy, or decompensated cirrhosis classified as Child–Pugh class C or accompanied by a history of portal hypertensive bleeding. 10.Creatinine clearance <30 mL/min, calculated using the Cockcroft–Gault formula. 11.Active autoimmune disease requiring high-dose corticosteroids or immunosuppressive therapy. 12.Major cardiovascular disease, unstable arrhythmia, or unstable angina within 3 months before initiation of study treatment. 13.Major surgery within 4 weeks before initiation of study treatment, except for diagnostic procedures. 14.Severe infection within 4 weeks before initiation of study treatment, including infection requiring hospitalization, bacteremia, or severe pneumonia. 15.Active infection requiring systemic therapy that is unlikely to be adequately controlled before or after surgery, as assessed by the investigator. 16.Symptomatic or uncontrolled central nervous system disease. 17.Pregnancy or breastfeeding. 18.Planned major surgery within 30 days after the index liver tumor resection. 19.Active alcohol dependence that would interfere with perioperative management, treatment adherence, or follow-up. 20.Inability to receive postoperative nadroparin calcium for venous thromboembolism prophylaxis. 21.Inability to complete study follow-up, concurrent participation in another clinical study that may interfere with study outcomes, unwillingness to participate, or inability to provide written informed consent. 22.Any clinically significant comorbidity or other condition that, in the investigator’s judgment, would make participation inappropriate or interfere with treatment evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major bleeding;Incidence of clinically relevant post-hepatectomy liver failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative length of hospital stay;Incidence of major postoperative complications;Incidence of composite thrombotic events;Thirty-day unplanned readmission rate;Incidence of clinically relevant non-major bleeding at 30 days post-surgery;Reoperation rate at 30 days post-surgery;30-Day Postoperative Mortality Rate;90-Day Postoperative Mortality Rate;Overall Incidence and Distribution by Grade of PHLF (Grades A–C);Quality of Life 30 Days After Surgery;Incidence of Bile Fistula 30 Days Postoperatively;Overt thrombocytopenia 30 days postoperatively;Wound infection 30 days post-surgery;Incidence of Postoperative Portal Vein Embolism;Incidence of Postoperative Hepatic Vein/Inferior Vena Cava Thrombosis or Budd–Chiari Syndrome;Postoperative Recovery of Liver Function;Incidence of Postoperative Abdominal Effusion or Intra-abdominal Bleeding;Pain Assessment; | — |
Countries
China
Contacts
Public ContactWang Lu
Fudan University Shanghai Cancer Center
Outcome results
None listed