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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03158792
• Date of registration: 09/04/2017
• Prospective Registration: No
• Primary sponsor: Lebanese American University
• Public title: Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function
• Scientific title: Evaluation of Non-Surgical Venous Thromboembolism Prophylaxis Dosing Strategies: Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function
• Date of first enrolment: October 24, 2015
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03158792
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: Phase 4

Countries of recruitment

Lebanon

Contacts

• Name: Nibal R Chamoun, PharmD
• Affiliation: Lebanese American University

Key inclusion & exclusion criteria

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



Age minimum: 70 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Impairment

Venous Thromboembolism

Intervention(s)

Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe

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

Primary Outcome(s)

Peak anti-Xa levels [Time Frame: Day 3 of thromboprophylaxis]

Secondary Outcome(s)

Objectively confirmed symptomatic or asymptomatic venous thromboembolism (VTE) including both deep vein thrombosis (DVT) and or pulmonary embolism (PE). [Time Frame: Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, whichever comes first.]

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.]

Trough anti-xa levels [Time Frame: Day 3 of thromboprophylaxis]

Secondary ID(s)

LAU.SOP.NC1.25/Jun/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors