NCT03483181

Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Using Propensity Score Matching

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Hanoi Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Thrombosis
• Deep Vein Thrombosis
• Surgery--Complications

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-11-01
• Completion: 2018-12-31
• First posted: 2018-03-30
• Last updated: 2018-03-30

Locations

1 site across 1 country: Vietnam