Venous thromboembolism. Embolism and thrombosis of unspecified vein
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Women aged 18 years or older. Women with uterine, ovarian, or cervical cancer undergoing laparotomy. Patients who are able to follow the 28-day medication regimen. Patients who sign the written informed consent form.
Exclusion criteria
Exclusion criteria: Known hypersensitivity to apixaban or enoxaparin. Previous history of vascular events. Previous long-term immobility or limb fracture. History of diseases predisposing to bleeding or thrombosis, such as antiphospholipid syndrome, hemophilia, or leukemia. Previous use of anticoagulant drugs before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of symptomatic venous thromboembolism, including deep vein thrombosis or pulmonary embolism. Timepoint: During follow-up up to 30 days after surgery. Method of measurement: Clinical assessment and confirmation by color Doppler ultrasonography for suspected deep vein thrombosis and computed tomography scan for suspected pulmonary embolism. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of bleeding events related to anticoagulant drug use. Timepoint: During follow-up up to 30 days after surgery. Method of measurement: Clinical assessment and patient questionnaire.;Medication adherence during the prophylaxis period. Timepoint: During the 28-day prophylaxis period after discharge. Method of measurement: Number of used doses divided by the total number of prescribed doses.;Patient treatment costs. Timepoint: At the end of the 28-day prophylaxis period after discharge. Method of measurement: Patient questionnaire and recorded treatment costs. | — |
Countries
Iran (Islamic Republic of)
Contacts
Oroumia University of Medical Sciences