venous thromboembolism,gynecologic malignancies
Conditions
Interventions
Rivaroxaban Research Group:Rivaroxaban 10mg orally once daily for 30 days 12-24h after surgery
Low molecular weight heparin control group:Subcutaneous injection of 4000 units of low molecular weight heparin was given 12-24h after surgery once a day during hospital
Rivaroxaban 10mg orally once daily during discharge
Until 30 days after surgery
Sponsors
Fujian Maternity and Child Health Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Women =18 years of age who are capable of providing written informed consent; ? All patients with suspected or confirmed gynecological malignancies (including ovarian cancer, uterine cancer, cervical cancer, vulvar cancer, vaginal cancer or other rare gynecological malignancies confirmed by pathological examination); ? gynecological malignancies operation was planned during hospitalization; ? Patients were able to follow up for 90 days.
Exclusion criteria
Exclusion criteria: ? The doctor decides that participating in the trial is not in the best interest of the patient; ? Thrombotic diseases (anticoagulant drugs have been used in the past three months); ? Long-term use of non-steroidal anti-inflammatory drugs; ? Strong suppressive agents using cytochrome P450 (CYP3A4) and/or glycoprotein P (P-GP) together (e.g., protease inhibitors, ketoconazole, itraconazole) and/or strong inducers using P-GP and CYP3A4 (e.g., rifampicin, rifambutin, rifapentine, phenytoin, phenobarbital, carbamazepine); ? Total bilirubin more than 2 times the upper limit of normal, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase more than 3 times the upper limit of normal; ? endogenous creatinine clearance = 30 mL/min; ? Patients with anticoagulant contraindications (risk of active bleeding, liver failure, hematopathy or contraindicated bleeding, and contraindicated rivaroxaban or low molecular weight heparin); ? Patients who were not diagnosed with gynecological malignancies during the operation; ? Pregnancy or breastfeeding; ? The presence of one of the following uncontrolled or unstable cardiovascular diseases: stroke, acute ischemia or myocardial infarction confirmed by electrocardiogram, and/or clinically significant arrhythmia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| venous thromboembolism; | — |
Secondary
| Measure | Time frame |
|---|---|
| major bleeding;Clinically relevant non-major bleeding;minor bleeding;all-cause death; | — |
Countries
China
Contacts
Public ContactJinghua Zhang
Fujian Maternity and Child Health Hospital
Outcome results
None listed