Clinical trial NCT06635317: Efficacy of Aspirin in Preventing Venous Thromboembolism
Official title: Efficacy of Arpirin in Preventing Venous Thromboembolism in Total Knee and Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Thromboembolism (VTE)
Total Joint Arthroplasty
Total Hip Arthroplasty (THA)
Keywords: Aspirin
Venous thromboembolism
Total knee replacement
Total hip replacement
Thromboprophylaxis
Lead sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Sponsor class: OTHER_GOV
First posted: 2024-10-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: All patients who underwent a preoperative Doppler ultrasound of the lower extremities to screen for VTE and received antibiotic prophylaxis with cephalothin 1 gram intravenously.

At six hours post-surgery, patients in the aspirin group received enoxaparin, 40 mg/day subcutaneously for 3 days, and aspirin, 100 mg/day orally for 25 days. Patients in the enoxaparin group received enoxaparin, 40 mg/day subcutaneously for 28 days, with the dose reduced to 20 mg for patients weighing less than 50 kg or with an estimated glomerular filtration rate less than 30 mL/min/1.73 m².

Additionally, all patients received pneumatic compression stockings postoperatively for at least 21 days as standard care.

Physical therapy was initiated on the day of surgery or postoperative day 1 and continued daily throughout the hospital stay.

Postoperative wound care and Doppler ultrasound evaluations were performed at two and four weeks postoperatively to detect any evidence of VTE.
Primary purpose: TREATMENT

Brief summary: Efficacy of aspirin and enoxaparin in preventing venous tromboembolism was compared after total knee or hip arthroplasty.

Detailed description: Background: Venous thromboembolism (VTE) remains a significant risk following joint replacements, despite advancements in prevention strategies. Aspirin-based therapies have gained popularity due to their perceived safety, ease of administration, and supportive evidence.This study aimed to compare the efficacy of aspirin and enoxaparin in preventing VTE after total knee or hip arthroplasty.

Methods: Sixty patients undergoing primary total knee or hip arthroplasty were randomized to receive either aspirin or enoxaparin. The primary outcome was symptomatic VTE within 90 days. Patients were followed up for Doppler ultrasound evaluations.

Eligibility criteria: Inclusion Criteria:

* All patients provided written informed consent.
* All patients who underwent primary total hip or total knee arthroplasty for osteoarthritis

Exclusion Criteria:

* preoperative anticoagulation (direct oral anticoagulant, warfarin, IMPROVE Bleeding Score more or equal to 7, dual antiplatelet therapy)
* medical contraindications (allergy, cancer, cardiac disease, kidney disease, or bleeding disorder precluding anticoagulation).

Primary outcomes:
measure: Symptomatic VTE
timeFrame: 90 days
Secondary outcomes:
measure: Wound bleeding
timeFrame: 90 days
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: ISSSTEP
Study officials:
References: