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

NCT07213713 | Not Yet Recruiting

• 1 other identifier: 7741
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Venous Thromboembolism; Obese Patients

Outcome Measures

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.

  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

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective observational study, multicentric. Target population: Patients with BMI 40 kg/m2 hospitalized, candidates for anticoagulation therapy in prophylaxis (PADUA score 4).

You may qualify if:

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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Erica De Candia Prof.ssa Erica De Candia, MD

CONTACT

0630156329; erica.decandia@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.ssa Erica De Candia

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share