Efficacy of Aspirin in Preventing Venous Thromboembolism
NCT ID: NCT06635317
Last Updated: 2024-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2022-04-24
2023-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
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.
TREATMENT
SINGLE
Study Groups
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Long term aspirin group
Long term aspirin group received enoxaparin, 40 mg/day subcutaneously for 3 days, and aspirin, 100 mg/day orally for 25 days
Aspirin
100 mg/day orally for 25 days
Enoxaparin group
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.
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.
Interventions
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Aspirin
100 mg/day orally for 25 days
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.
Eligibility Criteria
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Inclusion Criteria
* All patients who underwent primary total hip or total knee arthroplasty for osteoarthritis
Exclusion Criteria
* medical contraindications (allergy, cancer, cardiac disease, kidney disease, or bleeding disorder precluding anticoagulation).
ALL
No
Sponsors
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Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
OTHER_GOV
Responsible Party
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Ana Luisa Galicia Zamalloa
MD, MSc
Locations
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ISSSTEP
Puebla City, , Mexico
Countries
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Other Identifiers
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151.2022
Identifier Type: OTHER
Identifier Source: secondary_id
151.2022
Identifier Type: -
Identifier Source: org_study_id
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