Evaluation of Anti-Xa Activity in Patients With Severe Obesity After Subcutaneous Injection of Enoxaparin for Antithrombotic Prophylaxis at Two Different Sites.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Venous Thromboembolism, Obese Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Primary outcome measures
- 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]
Eligibility 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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07213713 · 7741