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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158792
• Other study ID #: LAU.SOP.NC1.25/Jun/2015
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2017
• Last updated: September 8, 2017
• Start date: October 24, 2015
• Est. completion date: July 13, 2017

Study information

• Verified date: September 2017
• Source: Lebanese American University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 13, 2017
• Est. primary completion date: July 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Enoxaparin 20Mg/0.2mL Prefilled Syringe
Enoxaparin 20mg subcutaneously once daily
• Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml
Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered

Locations

Country	Name	City	State
Lebanon	LAU Medical Center-Rizk Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Lebanese American University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak anti-Xa levels	Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given	Day 3 of thromboprophylaxis
Secondary	Trough anti-xa levels	Trough anti-Xa levels, drawn right before the third enoxaparin dose is given	Day 3 of thromboprophylaxis
Secondary	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.
Secondary	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.