Status:
NOT_YET_RECRUITING
Evaluation of Anti-Xa Activity in Patients With Severe Obesity After Subcutaneous Injection of Enoxaparin for Antithrombotic Prophylaxis at Two Different Sites.
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Venous Thromboembolism
Obese Patients
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- • age \>18 years,
- BMI \>40 kg/m2
- indication to primary or secondary thromboprophylaxis (Padua Score \> 4), as clinical practice
Exclusion
- • indication to full dose anticoagulant,
- creatinine clearance \<30 mL/min (based on Cockcroft-Gault equation using adjusted body weight),
- pregnant women,
- low platelet count (\<50.000/microL or \<100.000/microL plus additional risk factors for bleeding),
- active bleeding,
- active gastroduodenal ulcer,
- severe bleeding diathesis,
- recent/planned/emergency high bleeding-risk surgery/procedure,
- major trauma,
- acute intracranial hemorrhage,
- bleeding within the three months prior to admission,
- known hypersensitivity to enoxaparin (e.g. pruritus, urticaria, anaphylactic/anaphylactoid reactions),
- history of immune mediated heparin-induced thrombocytopenia (HIT),
- severe uncontrolled hypertension,
- diabetic or hemorrhagic retinopathy,
- concurrent administration of subcutaneous drugs (i.e. insulin, GLP-1 receptor agonists, etc.).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07213713
Start Date
October 1 2025
End Date
October 1 2027
Last Update
October 9 2025
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