Venous Thromboembolism
Conditions
Keywords
Chemoprophylaxis, Hip Surgery, Knee Surgery
Brief summary
This research study is attempting to answer the question of whether 81 mg aspirin once daily is as effective as 81 mg aspirin twice daily in preventing blood clots after total joint replacement surgery.
Interventions
DRUGAspirin
Non-enteric coated 81 mg Aspirin tablet.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years of age * Planning to undergo a primary total hip or knee arthroplasty
Exclusion criteria
* High risk patients for VTE as defined by: * History of venous thromboembolism * Active malignancy * Known pro thrombotic condition * BMI \> 40 * Patients requiring anticoagulation for pre-existing conditions * Patients with the contraindication for use of aspirin or nonsteroidal antiinflammatory drugs for reasons such as peptic ulcer disease, intolerance, others. * Patients not fluent in the language of the informed consent form * Prisoners * Pregnancy * Reported to have mental illness or belonging to a vulnerable population
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of symptomatic thromboembolic events | 90 days | Efficacy of prophylaxis will be reported as the number of reported incidence of symptomatic Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of specific adverse events | 90 days | Efficacy of prophylaxis will be reported as the number of reported incidence of specific adverse events including gastrointestinal (GI) complications, post-operative hematoma, bleeding and wound complications and infections. |
Countries
United States
Contacts
CONTACTRamakanth Yakkanti, MD
PRINCIPAL_INVESTIGATORVictor Hernandez, MD
University of Miami
Outcome results
None listed