Evaluation of Anti-Xa Activity in Patients With Severe Obesity After Subcutaneous Injection of Enoxaparin for Antithrombotic Prophylaxis at Two Different Sites.
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study ID
- NCT07213713
- Status
- Not Yet Recruiting
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Conditions
- Obese Patients
- Venous Thromboembolism
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
To evaluate appropriateness of enoxaparin bioavailability at two different sites of subcutaneous administration (arms or abdomen) in primary or secondary prevention of thromboembolism in a population of patients with severe obesity
Key Dates
- First listed
- Oct 9, 2025
- Start date
- Oct 1, 2025
- Status verified
- Oct 2025
- Primary completion
- Oct 1, 2027
- Completion
- Oct 1, 2027
Study Design
- Enrollment
- 80 participants (estimated)
Primary Outcome Measure
The primary outcome is the achievement of both target anti-factor Xa levels at peak, defined as 0.2 to 0.4 IU/mL, and at trough, defined as >0.1 IU/mL. [ Time Frame: 24 months ]
Central Contacts
- Erica De Candia Prof.ssa Erica De Candia, MD0630156329
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