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IRCT20230419057967N1 IRCT 2023-12-09 Bagheiat-allah University of Medical Sciences Comparison of the preventive effects of Apixaban and Enoxaparin on the postoperative vascular thromboembolism Comparison of the preventive effects of Apixaban and Enoxaparin on the postoperative vascular thromboembolism in patients undergoing surgery with gynecological and colorectal cancers 2024-01-21 anticipated 160 Complete https://irct.ir/trial/69794 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: 5000 units of Heparin (Caspiantamin, Iran) are injected 30 minutes before skin incision, subcutaneously. 18 to 24 hours after the termination of the operation, 0.5 mg/kg enoxaparin (Iran Hormone, Iran) is injected subcutaneously and continues until discharge per day. After discharge for 28 days, 2.5 mg of apixaban (Exir, Iran) will be administered orally twice a day. Intervention 2: Control group: 5000 units of Heparin (Caspiantamin, Iran) are injected 30 minutes before skin incision, subcutaneously. 18 to 24 hours after the termination of the operation, 0.5 mg/kg enoxaparin (Iran Hormone, Iran) is injected subcutaneously and continues until discharge per day. After discharge for 28 days, 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.Takizad and any analysis must be done with her opinion. Where to obtain: Dr. Takizad through email (farimatakizad@yahoo.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. Takizad. Comments:
public Farima Takizad
Bagheiat-allah Hospital, Mullasadra Street, Vanak Square.
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8805 0436 farimatakizad@yahoo.com Bagheiat-allah University of Medical Sciences scientific Farima Takizad
Bagheiat-allah Hospital, Mullasadra Street, Vanak Square.
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8805 0436 farimatakizad@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with gynecological or colorectal cancers (rectum and colon) undergo laparotomy. 18 years 89 years Both Use of non-steroidal anti-inflammatory drugs for more than one year Having other types of cancers History of thromboembolism Having severe kidney or liver diseases Having coagulation or bleeding disorders Using thrombogenic drugs Pregnancy or breastfeeding I82 Other venous embolism and thrombosis Prevention Prevention Intervention group: 5000 units of Heparin (Caspiantamin, Iran) are injected 30 minutes before skin incision, subcutaneously. 18 to 24 hours after the termination of the operation, 0.5 mg/kg enoxaparin (Iran Hormone, Iran) is injected subcutaneously and continues until discharge per day. After discharge for 28 days, 2.5 mg of apixaban (Exir, Iran) will be administered orally twice a day. Control group: 5000 units of Heparin (Caspiantamin, Iran) are injected 30 minutes before skin incision, subcutaneously. 18 to 24 hours after the termination of the operation, 0.5 mg/kg enoxaparin (Iran Hormone, Iran) is injected subcutaneously and continues until discharge per day. After discharge for 28 days, 0.5 mg/kg enoxaparin will be administered subcutaneously daily for 28 days. The occurrence of major bleeding including hematoma and pelvic and abdominal bleeding. Timepoint: Three times, 30, 60 and 90 days after surgery. Method of measurement: Clinical symptoms and paraclinical findings. Non-major bleeding incidence with clinical significance (requiring intervention). Timepoint: Three times, 30, 60 and 90 days after surgery. Method of measurement: Clinical symptoms and paraclinical findings. Bagheiat-allah University of Medical Sciences Approved 2023-09-30 Ethics committee of Bagheiat-allah University of Medical Sciences Bagheiat-allah Hospital, Mullasadra Street, Vanak Square. Tehran Tehran Iran (Islamic Republic of)