ThrombosisNCT03483181
Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Using Propensity Score Matching
An observational study of Thrombosis and Deep Vein Thrombosis, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Deep Vein Thrombosis, Surgery--Complications
- What is being tested?
- Xarelto (rivaroxaban) and Lovenox (enoxaparin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteVietnam
- Study dates
- Jan 2018to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older who experienced a orthopedic surgeries during the hospitalization were the initial target population.
Who may be able to join
- Undergo Orthopedic Surgery
- Thromboprophylaxis Decision Taken
- At least 18 years of age
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
- Conditions
- Thrombosis, Deep Vein Thrombosis, Surgery--Complications
- Being tested
- Xarelto (rivaroxaban), Lovenox (enoxaparin)
- Medical subject headings
- Thrombosis, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic surgery patient records | Medical records from patients aged 18 years or older with orthopedic surgeries during the hospitalization Receives: Drug: Xarelto (rivaroxaban); Drug: Lovenox (enoxaparin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 year
Death
Death from any cause including venous thromboembolism
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: After 4 hours of the first dose and up to 2 days after the last dose of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study startJan 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Bach Mai Hospital
- Responsible party
- Principal investigator, Bui My Hanh, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483181
- Sponsor's protocol ID
- ĐTĐL.CN.53/16
- Status last verified
- Mar 2018
- First submitted
- 19 Mar 2018
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Using Propensity Score Matching
- ClinicalTrials.gov ID
- NCT03483181
- Acronym / sponsor ID
- ĐTĐL.CN.53/16
- Conditions
- Thrombosis, Deep Vein Thrombosis, Surgery--Complications
- Study type
- Observational
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Collaborators
- Bach Mai Hospital
- Study start
- Jan 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthopedic surgery patient records | – | Drug: Xarelto (rivaroxaban), Drug: Lovenox (enoxaparin)Medical records from patients aged 18 years or older with orthopedic surgeries during the hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older who experienced a orthopedic surgeries during the hospitalization were the initial target population.
Key inclusion criteria (3 listed)
- Undergo Orthopedic Surgery
- Thromboprophylaxis Decision Taken
- At least 18 years of age
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xarelto (rivaroxaban)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. | Drug | Orthopedic surgery patient records |
| Lovenox (enoxaparin)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. | Drug | Orthopedic surgery patient records |
Primary outcome
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.
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.
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.
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
Death
Time frame: 1 year
Death from any cause including venous thromboembolism
2 secondary outcomes
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis and Deep Vein Thrombosis, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep-vein thrombosis (DVT) (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.