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IRCT20171223038021N1 IRCT 2018-05-09 Babol University of Medical Sciences Comparison of the effectiveness of anticoagulant protocols in orthopedic patients Comparing the effectiveness and complications of Aspirin to Heparin and Enoxaparin in preventing venous thromboembolism in patients with fracture of extremities undergoing Open Reduction Internal Fixation (ORIF) surgery 2017-03-21 anticipated 150 Complete https://irct.ir/trial/28422 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The patients will be assigned randomly to 3 groups and will receive of these treatments accordingly for venous thromboembolism prophylaxis: 1. Aspirin tab., 80 mg, daily; 2. Enoxaparin Amp., 40 mg, subcutaneous, daily; 3. Heparin Amp., 5000 IU, subcutaneous, daily, Randomization description: simple randomization using a random numbers table, Blinding description: Participants in each of the 3 study groups (aspirin, enoxaparin and heparin) know they're being treated with one of these 3 drugs (for venous thromboembolism prophylaxis) but don't know which one exactly. N/A Condition 1: pulmonary embolism. Condition 2: Deep vein thrombosis. Condition 3: deep vein thrombosis. Intervention 1: Intervention group: َAspirin 80 mg tablet daily for 2 weeks after surgery. Intervention 2: Intervention group: Heparin 5000 IU Amp. twice daily, subcutaneous for 2 weeks after surgery. Intervention 3: Intervention group: Enoxaparin 40 mg Amp. daily, subcutaneous for 2 weeks after surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Farbod Zahedi Tajrishi
Ferdows 14, West Amirkabir Ave.
Babol Iran (Islamic Republic of) 4718948846 +98 11 3233 3103 f.zahedi@mubabol.ac.ir Babol University of Medical Sciences scientific Rahmatollah Jokar
Shahid Beheshti Teaching Hospital, Sargord Ghasemi St.
Babol Iran (Islamic Republic of) 4716681451 +98 11 3225 2071 dr.rjokar1@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Trauma patients with initial diagnosis of extremity bone fracture who refer to Babol Shahid Beheshti Hospital in 2017-2018 and who undergo Open Reduction and Internal Fixation (ORIF) followed by receiving prophylactic anticoagulant therapy to prevent venous thromboembolism no limit no limit Both hemorrhagic disorders diseases causing hypergoagulable state history of stroke recent major surgery or the need for one during current admission due to causes other than fracture history of recent major trauma other than the one that caused the fracture history of myocardial infarction uncontrolled hypertension during the past 3 months gastrointestinal and/or urinary bleeding during the past 6 months overt (known) liver and/or kidney disease NSAID use up to 1 week prior to surgery allergy to heparin active malignancy pregnant women I26 I80.2 I80.1 Pulmonary embolism Phlebitis and thrombophlebitis of other and unspecified deep vessels of lower extremities Phlebitis and thrombophlebitis of femoral vein Prevention Prevention Prevention Intervention group: َAspirin 80 mg tablet daily for 2 weeks after surgery Intervention group: Heparin 5000 IU Amp. twice daily, subcutaneous for 2 weeks after surgery Intervention group: Enoxaparin 40 mg Amp. daily, subcutaneous for 2 weeks after surgery Occurrence of pulmonary embolism in each venous thromboembolism prophylaxis method (including ASA, heparin and enoxaparin). Timepoint: 2 and 4 weeks after surgery. Method of measurement: Patients will be followed-up by the researcher. 2 and 4 weeks after surgery, patients will be re-evaluated with regards to any recent history of admission to hospital due to pulmonary embolism after the surgery. They will also be asked about the occurrence of symptoms such as acute unexplained dyspnea. A diagnosis of pulmonary embolism is definite when the patients presents any official hospital document with a confirmed diagnosis of pulmonary embolism or a when a combination of the mentioned symptoms and radiologic findings (such as a CT angiogram suggesting pulmonary embolism) are present. Occurrence of deep vein thrombosis in each venous thromboembolism prophylaxis method (including ASA, heparin and enoxaparin). Timepoint: 2 and 4 weeks after surgery. Method of measurement: Patients will be followed-up by the researcher. 2 and 4 weeks after surgery, patients will be re-evaluated with regards to any recent history of admission to hospital due to deep vein thrombosis after the surgery. They will also be asked about the occurrence of symptoms such as cramps, pain, erythema, swelling or tenderness in the posterior portion of their legs that has not resolved spontaneously or have worsened through time. A diagnosis of deep vein thrombosis is definite when the patients presents any official hospital document with a confirmed diagnosis of the condition or a when a combination of the mentioned symptoms and radiologic findings (such as a doppler ultrasonogram of the veins of lower extremities suggesting deep vein thrombosis) are present. Gastrointestinal bleeding. Timepoint: 2 and 4 weeks aftrer surgery. Method of measurement: asking the patients about any history of melena, bloody stool or vomiting blood after surgery. Hemorrhagic stroke. Timepoint: 2 and 4 weeks after surgery. Method of measurement: asking the patients about any history of admission due to hemorrhagic stroke after surgery. Hemarthrosis. Timepoint: 2 and 4 weeks after surgery. Method of measurement: history, physical exam and radiographic findings consistent with hemarthrosis. Allergic reaction to the assigned medication. Timepoint: 2 and 4 weeks after surgery. Method of measurement: history and signs and symptoms consistent with allergic reaction to the medication used for venous thromboembolism prophylaxis. Babol University of Medical Sciences Approved 2017-08-27 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafrooz Street Babol Mazandaran Iran (Islamic Republic of)