Clinical trial
Evaluation of Anti-Xa Activity in Patients With Severe Obesity After Subcutaneous Injection of Enoxaparin for Antithrombotic Prophylaxis at Two Different Sites.
Opening soon · Not applicable · 0 countries · Registry ID NCT07213713
Opening soonNot applicableObservational
What this study is about
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
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionVenous Thromboembolism, Obese Patients
Full registry criteria
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.).
Treatments and study arms
The registry does not list a named intervention.
Primary outcomes
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
Study locations
0 locations were listed when this page was built. The first 40 are shown.
No public site location was included in this record. Check the original registry for updates.