Not Yet RecruitingNot Applicable

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

80 participantsStarted 2025-10-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 24 months

Trial details

NCT IDNCT07213713

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-10-01

Contact for this trial

Erica De Candia Prof.ssa Erica De Candia, MD

0630156329 erica.decandia@policlinicogemelli.it

View on ClinicalTrials.gov More Venous Thromboembolism trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.