Comparing daily doses of aspirin to prevent blood clots after joint surgery
Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For Venous Thromboembolism (VTE) Following Total Joint Arthroplasty - A Multi-center Prospective Randomized Control Trial.
This study tests if taking a low dose of aspirin once a day is just as good as taking it twice a day to prevent blood clots in people having hip or knee surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5478 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT04295486 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether taking 81 mg of aspirin once daily is as effective as taking it twice daily for preventing venous thromboembolism (VTE) in patients undergoing total hip or knee arthroplasty. The study aims to determine the optimal dosing strategy for aspirin chemoprophylaxis in this patient population. Participants will be monitored for the occurrence of blood clots following their surgery. The trial is designed to provide insights into the most effective aspirin regimen for reducing VTE risk.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are planning to undergo primary total hip or knee arthroplasty.
Not a fit: Patients with a history of venous thromboembolism, active malignancy, or other high-risk factors for VTE may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved guidelines for aspirin use in preventing blood clots after joint replacement surgeries.
How similar studies have performed: Other studies have explored aspirin dosing for VTE prevention, but this specific comparison of once versus twice daily dosing is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami, Florida
- University of Miami Hospital — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Victor Hernandez, MD — University of Miami
- Study coordinator: Ramakanth Yakkanti, MD
- Email: ramakanth.yakkanti@jhsmiami.org
- Phone: 502-689-3127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.