Evaluation of Anti-Xa Activity in Patients With Severe Obesity After Subcutaneous Injection of Enoxaparin for Antithrombotic Prophylaxis at Two Different Sites.

Not yet recruiting

• Conditions: Venous Thromboembolism; Obese Patients

• Registration Number: NCT07213713
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 of patients with severe obesity

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-01
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• age >18 years,

• BMI >40 kg/m2
• indication to primary or secondary thromboprophylaxis (Padua Score > 4), as clinical practice

Exclusion Criteria

• 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.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	24 months	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