Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.

Completed

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Key information

Conditions

Osteoarthritis, Hip Arthritis Bone Diseases Femoral Fractures Femoral Neck Fractures Femur Head Necrosis Fractures, Bone Hip Fractures Hip Injuries Joint Diseases Leg Injuries Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Male or female without childbearing potential aged ≥20 years who were scheduled for elective primary THA

Exclusion criteria

recent history of active bleeding or VTE
known genetic disorder associated with bleeding tendency or any condition related with an increased risk of bleeding
persistent blood pressure of ≥160mmHg systolic and/or ≥100 mmHg diastolic at baseline
myocardial infarction or cerebrovascular accident within three months of the scheduled surgery
major surgery in the prior three months
renal insufficiency with a creatinine clearance <60mL/min , hepatic failure combined with coagulopathy, or thrombocytopenia (platelets < 100,000/mm³), or planned indwelling epidural catheter for > 6 hours after the end of surgery

Treatment and study plan

Rivaroxaban

Drug

Rivaroxaban was taken orally in a dosage of 10mg once daily

Enoxaparin

Drug

Enoxaparin was injected subcutaneously in a dosage of 40mg once daily

Normal Saline

Other

subcutaneous injection of 1 cc of normal saline once daily

Primary outcomes

Major wound complication

Time frame: 2 weeks

hematoma : size, site woozing : frequency, amount, dressing change count infection : culture

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Efficacy and Safety for Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Mar 5, 2015
Registry last updated: Mar 5, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed