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

Phase 4

Completed

• Conditions: Renal Impairment; Venous Thromboembolism
• Interventions: Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml; Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe

• Registration Number: NCT03158792
• Lead Sponsor: Lebanese American University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-24
• Study First Submitted: 2017-04-09
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-18
• Primary Completion: 2017-07-13
• Study Completion: 2017-07-13
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Non-surgical patients
• 70 years of age or older
• With renal impairment (creatinine clearance ≤35ml/min)
• Requiring pharmacological thromboprophylaxis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin 30 mg	Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml	-
Enoxaparin 20 mg	Enoxaparin 20Mg/0.2mL Prefilled Syringe	-

Primary Outcome Measures

Name	Time	Method
Peak anti-Xa levels	Day 3 of thromboprophylaxis	Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given

Secondary Outcome Measures

Name	Time	Method
Trough anti-xa levels	Day 3 of thromboprophylaxis	Trough anti-Xa levels, drawn right before the third enoxaparin dose is given
Bleeding according to the GUSTO bleeding criteria.	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).	Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, whichever comes first.	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).

Trial Locations

Locations (1)

LAU Medical Center-Rizk Hospital; 🇱🇧 Beirut, Lebanon