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NCT Number: NCT03158792

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

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Impairment Renal Insufficiency Thromboembolism Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LAU Medical Center-Rizk Hospital

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin 20Mg/0.2mL Prefilled Syringe

Drug

Enoxaparin 20mg subcutaneously once daily

Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml

Drug

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Lebanese American University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 18, 2017
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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