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NCT Number: NCT07213713

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Primary outcomes

  1. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Erica De Candia Prof.ssa Erica De Candia, MD

CONTACT

[email protected]

0630156329

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: EPOS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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