Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
ConditionVenous Thromboembolism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
> 18 years of age
Planning to undergo a primary total hip or knee arthroplasty
Disqualifiers
History of venous thromboembolism
Active malignancy
Known pro thrombotic condition
BMI > 40
Trial design
Design model
Parallel
Treatments tested in this trial
Aspirin
DrugNon-enteric coated 81 mg Aspirin tablet.
Treatment groups
5,478 Participants
are divided into 2 treatment groupsGroup A: Treatment Once DailyExperimental treatment 1 intervention
Group B: Treatment Twice DailyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of symptomatic thromboembolic events
Efficacy of prophylaxis will be reported as the number of reported incidence of symptomatic Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT).
Time frame
90 daysSecondary outcomes
1
Incidence of specific adverse events
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.
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov