Condition 1: pulmonary embolism. Condition 2: Deep vein thrombosis. Condition 3: deep vein thrombosis. Pulmonary embolism Phlebitis and thrombophlebitis of other and unspecified deep vessels of lower extremities Phlebitis and thrombophlebitis of femoral vein
Conditions
Interventions
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.
Sponsors
Babol University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarbod Zahedi Tajrishi
Babol University of Medical Sciences
Outcome results
None listed