An observational study in Thrombosis, Deep Vein Thrombosis and Surgery--Complications, sponsored by Hanoi Medical University. Withdrawn at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Hanoi Medical University · Observational
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common post-operative complication. The necessity for anticoagulant therapy after orthopedic surgeries is widely understood, but treatment administration patterns in the prevention of venous thromboembolism (VTE) after orthopedic surgeries during the hospital stay have yet to be examined.
The main objective of this study is to perform a comparative effectiveness review examining the benefits and harms associated with venous thromboembolism prophylaxis in patients undergoing orthopedic surgeries.
It is around efficacy and safety evaluation of using anticoagulant for thromboprophylaxis in patients undergoing orthopedic surgeries taking into the account the reliable selection of patients most benefit.
The aims of this study is to analyze patient records in teaching hospitals database of our country (including: Hanoi Medical University, Bach Mai Hospital, Cho Ray Hospital, Viet Duc University Hospital) and compare the outcomes and costs between different types of anticoagulant medications that were prescribed for the prevention of VTE following orthopedic surgeries. This analysis will assess and quantify the outcomes, resource utilization, and cost of care for patients receiving rivaroxaban or enoxaparin. The outcomes of interest include the occurence of DVT and PE, rates of major bleeds, medical resource utilization, and total costs (medical plus pharmacy).
Patients aged 18 years or older who experienced a orthopedic surgeries during the hospitalization were the initial target population.
Exclusion Criteria:
Medical records from patients aged 18 years or older with orthopedic surgeries during the hospitalization
Drug: Xarelto (rivaroxaban) · Drug: Lovenox (enoxaparin)
An oral anticoagulant medication for the prevention of VTE (Venous thromboembolism) related to orthopedic surgery. Patients received rivaroxaban during one day prior to or two days after orthopedic surgery during the hospitalization.
An injectable anticoagulant medication for the prevention of VTE (Venous thromboembolism) related to orthopedic surgery. Patients received enoxaparin during one day prior to or two days after orthopedic surgeries during the hospitalization.
Deep-vein thrombosis (DVT)
The frequency of Deep-vein thrombosis Symptoms and signs of DVT may include unilateral leg swelling, pain in the affected leg, calf tenderness in affected leg, increased leg warmth, erythema of affected leg, or a "palpable cord" may be felt in the affected leg.
Time frame: 1 year
Non-fatal pulmonary embolism (PE)
Frequency of pulmonary embolism (non-fatal) Regarding Pulmonary Embolism (PE), diagnosis is suspected in patients with dyspnea, tachypnea, pleuritic chest pain, cough, and/or fever. Diagnosis begins with initial risk stratification "Wells Clinical Model for Evaluating the Pretest Probability of pulmonary embolism (PE) " based on presence of shock or persistent hypotension to identify patients at high risk of early mortality.
Time frame: 1 year
Mean length of hospital stay in days
Length of hospital stay was obtained from the discharge record and was defined as the number of days from patient admission to the hospital for orthopaedic surgeries until discharge from the hospital.
Time frame: 1 year
Total cost of care for index hospitalization in Vietnamese dong (VND)
The mean total costs (medical plus pharmacy costs) from patient records in each antithrombotic cohort from the index hospitalization
Time frame: 1 year
Death
Death from any cause including venous thromboembolism
Time frame: 1 year
Major bleeding risk
The incidence of major bleeding beginning after the first dose of the study drug and up to 2 days after the last dose of the study drug (on-treatment period). Major bleeding is defined as bleeding that is fatal, occurs in a critical organ (e.g., retroperitoneal, intracranial, intraocular, and intraspinal bleeding), or requires reoperation or extra surgical-site bleeding that was clinically overt and is associated with a fall in the hemoglobin level of at least 2 g per deciliter or that requires transfusion of 2 or more units of whole blood or packed cells.
Time frame: After 4 hours of the first dose and up to 2 days after the last dose of the study drug
Other on-treatment bleeding
The incidence of major bleeding beginning after the first dose of the study drug and up to 2 days after the last dose of the study drug (on-treatment period). Major bleeding is defined as bleeding that is fatal, occurs in a critical organ (e.g., retroperitoneal, intracranial, intraocular, and intraspinal bleeding), or requires reoperation or extra surgical-site bleeding that was clinically overt and is associated with a fall in the hemoglobin level of at least 2 g per deciliter or that requires transfusion of 2 or more units of whole blood or packed cells.
Time frame: After 4 hours of the first dose and up to 2 days after the last dose of the study drug
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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This study is withdrawn, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Hanoi Medical University