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NCT Number: NCT03483181

Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Using Propensity Score Matching

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).

Why the study stopped: After further evaluation, the secondary data source was determined to be insufficient to address the study objectives. No prospective patient enrollment was planned, and the study was not initiated.
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Key information

Conditions

Thrombosis Cardiovascular Diseases Deep Vein Thrombosis Embolism and Thrombosis Surgery--Complications Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanoi Medical University

Hanoi, 10000, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergo Orthopedic Surgery
  • Thromboprophylaxis Decision Taken
  • At least 18 years of age

Exclusion criteria

  • Planned intermittent pneumatic compression
  • A requirement for anticoagulant therapy that could not be stopped
  • Severe hypersensitivity reaction (eg, anaphylaxis) to rivaroxaban or enoxaparin.
  • Received another anticoagulant for more than 24 hours
  • Active bleeding or a high risk of bleeding
  • Thrombocytopenia associated with a positive test for antiplatelet antibody.
  • Warfarin associated international normalized ratio (INR) more than 1.5 on the day of the surgery
  • Conditions preventing bilateral venography
  • Intensive care unit (ICU) stay after surgery
  • Pregnant or breast-feeding
  • Creatinine clearance less than 30 ml per minute or acute renal failure before the surgery or at any point during the study period.
  • Moderate or Severe (Child Pugh B or C) hepatic Impairment or in patients with any hepatic disease associated with coagulopathy.
  • Concomitant use of drugs that are both P--glycoprotein inhibitors and moderate to strong cyp3a4 (ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir & conivaptan)
  • Creatinine clearance (CrCl) 15 to 80 mL/min and concurrent use of P-glycoprotein inhibitors or moderate CYP3A4 inhibitors (eg, abiraterone acetate, diltiazem, dronedarone, erythromycin, verapamil)

Treatment and study plan

Xarelto (rivaroxaban)

Drug

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.

Lovenox (enoxaparin)

Drug

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.

Primary outcomes

  1. Deep-vein thrombosis (DVT)

    Time frame: 1 year

    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.

  2. Non-fatal pulmonary embolism (PE)

    Time frame: 1 year

    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.

  3. Mean length of hospital stay in days

    Time frame: 1 year

    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.

  4. Total cost of care for index hospitalization in Vietnamese dong (VND)

    Time frame: 1 year

    The mean total costs (medical plus pharmacy costs) from patient records in each antithrombotic cohort from the index hospitalization

  5. Death

    Time frame: 1 year

    Death from any cause including venous thromboembolism

Secondary outcomes

  1. Major bleeding risk

    Time frame: After 4 hours of the first dose and up to 2 days after the last dose of the study drug

    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.

  2. Other on-treatment bleeding

    Time frame: After 4 hours of the first dose and up to 2 days after the last dose of the study drug

    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.

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Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Collaborators

  • Bach Mai Hospital

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2018
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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