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

Lebanese American University

Status and phase

Completed

Phase 4

Conditions

Venous Thromboembolism

Renal Impairment

Treatments

Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe

Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml

Study type

Interventional

Funder types

Other

Identifiers

NCT03158792

LAU.SOP.NC1.25/Jun/2015

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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