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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Venous Thromboembolism; Obese Patients

Study type: Observational

Funder types: Other

Identifiers

NCT07213713

7741

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.).