Femoral Neck Fractures, Femur Head Necrosis, Osteoarthritis, Hip
Conditions
Brief summary
This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.
Interventions
DRUGRivaroxaban
Rivaroxaban was taken orally in a dosage of 10mg once daily
DRUGEnoxaparin
Enoxaparin was injected subcutaneously in a dosage of 40mg once daily
OTHERNormal saline
subcutaneous injection of 1 cc of normal saline once daily
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major wound complication | 2 weeks | hematoma : size, site woozing : frequency, amount, dressing change count infection : culture |
Outcome results
None listed