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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Non-Surgical Venous Thromboembolism Prophylaxis Dosing Strategies: Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function

Conditions
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Venous Thromboembolism, Renal Impairment

Intervention / Treatment
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* Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe
* Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enoxaparin 20 mg<br> | Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe<br>* Enoxaparin 20mg subcutaneously once daily<br>|
| Active Comparator: Enoxaparin 30 mg<br> | Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml<br>* Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak anti-Xa levels | Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given | Day 3 of thromboprophylaxis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough anti-xa levels | Trough anti-Xa levels, drawn right before the third enoxaparin dose is given | Day 3 of thromboprophylaxis | 
| 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). | 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). | Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, whichever comes first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulation, Thromboprophylaxis, Anti-Xa levels, Elderly, Prevention, Enoxaparin, Low molecular weight heparin