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NCT07213713Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
2 Oct 2025
Start date
1 Oct 2025
Primary completion date
1 Oct 2027
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Diseases
Obesity
NCT number
NCT07213713

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From 1 Oct 2025 to the primary completion date, 1 Oct 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • bleeding within the three months prior to admission,
  • concurrent administration of subcutaneous drugs (i.e. insulin, GLP-1 receptor agonists, etc.).

Other illness

  • active bleeding,
  • active gastroduodenal ulcer,
  • severe bleeding diathesis,
  • recent/planned/emergency high bleeding-risk surgery/procedure,
  • acute intracranial hemorrhage,
  • known hypersensitivity to enoxaparin (e.g. pruritus, urticaria, anaphylactic/anaphylactoid reactions),
  • history of immune mediated heparin-induced thrombocytopenia (HIT),
  • severe uncontrolled hypertension,

Lab values

  • creatinine clearance \<30 mL/min (based on Cockcroft-Gault equation using adjusted body weight),
  • low platelet count (\<50.000/microL or \<100.000/microL plus additional risk factors for bleeding),

Other

  • pregnant women,
  • major trauma,
  • diabetic or hemorrhagic retinopathy,

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.