Inclusion Criteria |
Female patients 18 years of age or older |
Have undergone major gynecological cancer surgery (staging
surgery, debulking surgery, total or radical hysterectomy,
unilateral or bilateral salpingo-oophorectomy, omentectomy,
lymph node removal, open or laparoscopic access) |
Have signed informed consent |
Have received thromboprophylaxis with low-molecular-weight
heparin, fondaparinux, or unfractionated heparin during the
index hospitalization |
Exclusion Criteria |
Age < 18 years |
Refusal of informed consent |
Physician's decision that involvement in the trial was not
in the patient's best interest |
Patients with a medical indication for anticoagulation
therapy at the time of inclusion (for example, diagnosis of
venous thromboembolism, atrial fibrillation, mechanical
valve prosthesis) |
Patients with contraindications to anticoagulation (active
bleeding, liver failure, blood dyscrasia, or prohibitive
hemorrhagic risk in the investigator's assessment) |
Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or
glycoprotein P (P-gp) (eg, protease inhibitors,
ketoconazole, Itraconazole) and/or use of P-gp and strong
inducers of CYP3A4 (how but not limiting
rifampicin/rifampicin, rifabutin, rifapentine, phenytoin,
phenobarbital, carbamazepine or St. John's wort) |
Creatinine clearance <30 ml / min |
Pregnancy or breastfeeding |
Known HIV infection |
Presence of one of the following uncontrolled or unstable
cardiovascular diseases: stroke, ECG confirmed acute
ischemia or myocardial infarction, and/or clinically
significant dysrhythmia |