Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function

Lebanese American University32 enrolled

Overview

This is a clinical trial including non-surgical patients, 70 years of age or older, with renal impairment requiring pharmacological venous thromboembolism prevention during hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Both dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney function in different countries. Therefore, this study aims to evaluate the efficacy and safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels, thrombosis and bleeding events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Venous Thromboembolism Renal Impairment

Interventions

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Non-surgical patients * 70 years of age or older * With renal impairment (creatinine clearance ≤35ml/min) * Requiring pharmacological thromboprophylaxis Exclusion Criteria: * Indication for a treatment dose of anticoagulant treatment * Knee surgery or hip surgery within 10 to 35 days, respectively * Surgery, trauma, hemodialysis, peritoneal dialysis, or bleeding * History of heparin-induced thrombocytopenia * Known or suspected hypersensitivity to any component of study drug * Patients with an excessive risk of bleeding and not eligible for pharmacological thromboprophylaxis based on physician assessment or due to any of the 3 major risk factors including active gastroduodenal ulcer, bleeding within the past three months prior to hospital admission, or a platelet count of \<50,000 platelets/ mm3

Outcomes

Primary Outcomes

Peak anti-Xa levels

Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given

Time frame: Day 3 of thromboprophylaxis

Secondary Outcomes

Trough anti-xa levels

Trough anti-Xa levels, drawn right before the third enoxaparin dose is given

Time frame: Day 3 of thromboprophylaxis

Bleeding according to the GUSTO bleeding criteria.

Time frame: Bleeding within 30 days will be assessed from randomization till date of bleeding or date of discharge, whichever comes first.

Objectively confirmed symptomatic or asymptomatic venous thromboembolism (VTE) including both deep vein thrombosis (DVT) and or pulmonary embolism (PE).

Chart documentation of objectively detected DVT by either bilateral venography or duplex ultrasonography whereas PE detection by contrast enhanced computerized tomography scan (CT Scan) or Magnetic resonance imaging (MRI).

Time frame: Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, whichever comes first.