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IRCT20260209068807N1 IRCT 2026-05-18 Oroumia University of Medical Sciences Effect of Oral Apixaban Compared with Injectable Enoxaparin in Preventing Blood Clots After Gynecologic Cancer Surgery Comparison of oral anticoagulants with injectable anticoagulants for prophylaxis of thrombosis in patients undergoing laparotomy surgery 2026-05-22 anticipated 60 Recruiting https://irct.ir/trial/90094 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants will be randomly allocated to two study groups with a 1:1 allocation ratio. The unit of randomization is the individual participant. Simple randomization will be performed using the website [www.randomization.com](http://www.randomization.com). No stratified randomization will be used. The random sequence will be generated before participant enrollment. Eligible participants will be assigned to either the apixaban group or the enoxaparin group according to the generated random sequence. Allocation concealment will be maintained by using coded group assignments until the time of allocation. For data analysis, the groups will be coded as Group X and Group Y to reduce analysis bias. 3 Venous thromboembolism. Intervention group: Patients in this group will receive apixaban 2.5 mg oral tablet twice daily for 28 days after discharge.. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data related to the main study outcomes will be available upon reasonable request after publication of the final results. Shared data may include demographic variables, treatment group, occurrence of venous thromboembolism, bleeding events, medication adherence, and treatment costs. The study protocol, statistical analysis plan, informed consent form, clinical study report, and data dictionary will also be available upon reasonable request. Data will be shared only with researchers whose proposed use of the data is approved by the study investigators and, if required, by the relevant ethics committee. Data will be provided for scientific and non-commercial purposes only, after signing a data use agreement. When: The deidentified individual participant data and supporting documents will become available 6 months after publication of the final study results and will remain available for 5 years. To whom: The data and documents will be available to qualified researchers affiliated with academic, clinical, or research institutions for scientific and non-commercial purposes. Conditions: Data and documents will be shared only after approval of a written research proposal by the study investigators. The proposed analysis should be scientifically valid and related to venous thromboembolism prophylaxis, bleeding events, medication adherence, treatment costs, or related clinical outcomes. The applicant must agree not to attempt to identify participants and not to share the data with third parties. A data use agreement must be signed before data transfer. Where to obtain: Requests should be sent by email to the principal investigator, Dr. Arezou Divband, Urmia University of Medical Sciences. Email: divband.arezou@gmail.com. Requests should include the applicant’s affiliation, research proposal, planned analysis, and required documents or data. How to obtain: The applicant should submit a written request by email, including the research objective, requested data or documents, analysis plan, institutional affiliation, and ethics approval if required. The request will be reviewed by the study investigators within 4 weeks. If approved, the applicant will be asked to sign a data use agreement. After completion of the agreement, the approved deidentified data or documents will be provided within 2 to 4 weeks. Comments: Shared data will be deidentified and will not include names, national identification numbers, phone numbers, addresses, or other direct identifiers.
public Arezou Divband
Urmia, Hassani Street, Kosar Comprehensive Women's Educational and Medical Center
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3346 6472 kosar.hospital@umsu.ac.ir Oroumia University of Medical Sciences scientific Arezou Divband
Urmia, Hassani Street, Kosar Comprehensive Women's Educational and Medical Center
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3346 6472 kosar.hospital@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Female 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. I82.9 Embolism and thrombosis of unspecified vein Treatment - Drugs Intervention group: Patients in this group will receive apixaban 2.5 mg oral tablet twice daily for 28 days after discharge. 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. 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. Oroumia University of Medical Sciences Approved 2026-01-28 Urmia University of Medical Sciences (Research Ethics Committee) Emergency Room, Urmia University of Medical Sciences, Resalat Boulevard, Urmia, West Azerbaijan Province, Iran Urmia East Azarbaijan Iran (Islamic Republic of)