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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158792
Recruitment Status : Completed
First Posted : May 18, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Nibal Chamoun, 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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Renal Impairment Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : October 24, 2015
Actual Primary Completion Date : July 13, 2017
Actual Study Completion Date : July 13, 2017

Arm Intervention/treatment
Active Comparator: Enoxaparin 20 mg Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe
Enoxaparin 20mg subcutaneously once daily

Active Comparator: Enoxaparin 30 mg Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml
Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered




Primary Outcome Measures :
  1. Peak anti-Xa levels [ Time Frame: Day 3 of thromboprophylaxis ]
    Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given


Secondary Outcome Measures :
  1. Trough anti-xa levels [ Time Frame: Day 3 of thromboprophylaxis ]
    Trough anti-Xa levels, drawn right before the third enoxaparin dose is given

  2. 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. ]
  3. 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. ]
    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).



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158792


Locations
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Lebanon
LAU Medical Center-Rizk Hospital
Beirut, Lebanon
Sponsors and Collaborators
Lebanese American University
Investigators
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Principal Investigator: Nibal R Chamoun, PharmD Lebanese American University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nibal Chamoun, Clinical Assistant Professor of Pharmacy Practice and Clinical Coordinator, Lebanese American University
ClinicalTrials.gov Identifier: NCT03158792    
Other Study ID Numbers: LAU.SOP.NC1.25/Jun/2015
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nibal Chamoun, Lebanese American University:
Anticoagulation
Thromboprophylaxis
Anti-Xa levels
Elderly
Prevention
Enoxaparin
Low molecular weight heparin
Additional relevant MeSH terms:
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Renal Insufficiency
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases