Renal Impairment, Venous Thromboembolism
Conditions
Keywords
Anticoagulation, Thromboprophylaxis, Anti-Xa levels, Elderly, Prevention, Enoxaparin, Low molecular weight heparin
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.
Interventions
DRUGEnoxaparin 20Mg/0.2mL Prefilled Syringe
Enoxaparin 20mg subcutaneously once daily
DRUGEnoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml
Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered
Sponsors
Lebanese American University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak anti-Xa levels | Day 3 of thromboprophylaxis | Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Lebanon
Outcome results
None listed