Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Using Propensity Score Matching

March 23, 2018 updated by: Bui My Hanh, Hanoi Medical University

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 10000
        • Recruiting
        • Hanoi Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hoang Gia Du, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged 18 years or older who experienced a orthopedic surgeries during the hospitalization were the initial target population.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orthopedic surgery patient records
Medical records from patients aged 18 years or older with orthopedic surgeries during the hospitalization
Drug: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year
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.
1 year
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
1 year
Death
Time Frame: 1 year
Death from any cause including venous thromboembolism
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
After 4 hours of the first dose and up to 2 days after the last dose of the study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanoi Medical University

Collaborators

Bach Mai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ĐTĐL.CN.53/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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