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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07213713

Acronym

EPOS

Enrollment

Registered

2025-10-09

Start date

2025-10-01

Completion date

2027-10-01

Last updated

2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese Patients, Venous Thromboembolism

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.).

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

Primary ContactErica De Candia Prof.ssa Erica De Candia, MD

erica.decandia@policlinicogemelli.it0630156329

Outcome results