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IRCT20141231020504N2 IRCT 2023-05-03 Tehran University of Medical Sciences Comparison of the effect of apixaban and enoxaparin on the prevention of postoperative vascular thromboembolism Comparison of the effect of apixaban and enoxaparin on the prevention of postoperative vascular thromboembolism in women undergoing surgery for gynecological cancers 2023-05-22 anticipated 200 Complete https://irct.ir/trial/69708 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization method: Patients will be placed in two groups receiving apixaban group and enoxaparin group in a ratio of 1:1 using random blocks of four. In addition, interventions A (apixaban) or B (enoxaparin ) are determined by a lot, Blinding description: This study is performed single-blind, the study outcome assessor does not know the patient groups. 3 Venous embolism and thrombosis. Intervention 1: Intervention group: In the intervention group, 12 hours before surgery, 0.5 mg/kg enoxaparin (Iranhormone, Iran) will be injected subcutaneously, then 2.5 mg apixaban (Exir, Iran) will be administered orally twice a day for 28 days. Intervention 2: Control group: In the control group, 12 hours before surgery, 0.5 mg/kg enoxaparin (Iranhormone, Iran) will be injected subcutaneously. Then, 0.5 mg/kg enoxaparin will be administered subcutaneously daily for 28 days. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants When: After manuscript published To whom: No limitations Conditions: The data is only available to the project manager, Dr. Esmailzadeh and any analysis must be done with her opinion. Where to obtain: Dr. Esmailzadeh through email (dr.a.esmailzadeh@gmail.com) How to obtain: Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Esmailzadeh. Comments:
public Arezoo Esmailzadeh
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st
Tehran Iran (Islamic Republic of) 1461884513 +98 21 7788 3283 dr.a.esmailzadeh@gmail.com Tehran University of Medical Sciences scientific Arezoo Esmailzadeh
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st
Tehran Iran (Islamic Republic of) 1461884513 +98 21 7788 3283 dr.a.esmailzadeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with gynecological cancers (ovarian, uterine, cervical, or vulvar) undergo laparotomy surgery. 18 years 89 years Female Long-term use of non-steroidal anti-inflammatory drugs Patients with coagulation or bleeding disorders, severe kidney or liver diseases, valvular heart diseases Using thrombogenic drugs, selective serotonin reuptake inhibitors, or serotonin-norepinephrine reuptake inhibitors History of venous thromboembolism I82 Other venous embolism and thrombosis Prevention Prevention Intervention group: In the intervention group, 12 hours before surgery, 0.5 mg/kg enoxaparin (Iranhormone, Iran) will be injected subcutaneously, then 2.5 mg apixaban (Exir, Iran) will be administered orally twice a day for 28 days. Control group: In the control group, 12 hours before surgery, 0.5 mg/kg enoxaparin (Iranhormone, Iran) will be injected subcutaneously. Then, 0.5 mg/kg enoxaparin will be administered subcutaneously daily for 28 days. Major bleeding incidence. Timepoint: Once, 30 days after the surgery. Method of measurement: Questioning. Non-major bleeding incidence with clinical significance (requiring intervention). Timepoint: Once, 30 days after the surgery. Method of measurement: Questioning. Tehran University of Medical Sciences Approved 2021-08-04 Ethic committee of Tehran Uviversity of Medical Science Tehran University of Medical Sciences, Keshavarz blvd., Ghods st. Tehran Tehran Iran (Islamic Republic of)