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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI >40 kg/m2

indication to primary or secondary thromboprophylaxis (Padua Score > 4), as clinical practice

Disqualifiers

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,

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Time frame
24 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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