search
Back to results

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

Primary Purpose

Venous Thromboembolism, Renal Impairment

Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Enoxaparin 20Mg/0.2mL Prefilled Syringe
Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml
Sponsored by
Lebanese American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Anticoagulation, Thromboprophylaxis, Anti-Xa levels, Elderly, Prevention, Enoxaparin, Low molecular weight heparin

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LAU Medical Center-Rizk Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enoxaparin 20 mg

Enoxaparin 30 mg

Arm Description

Outcomes

Primary Outcome Measures

Peak anti-Xa levels
Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given

Secondary Outcome Measures

Trough anti-xa levels
Trough anti-Xa levels, drawn right before the third enoxaparin dose is given
Bleeding according to the GUSTO bleeding criteria.
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).

Full Information

First Posted
April 9, 2017
Last Updated
September 8, 2017
Sponsor
Lebanese American University
search

1. Study Identification

Unique Protocol Identification Number
NCT03158792
Brief Title
Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 24, 2015 (Actual)
Primary Completion Date
July 13, 2017 (Actual)
Study Completion Date
July 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lebanese American University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Renal Impairment
Keywords
Anticoagulation, Thromboprophylaxis, Anti-Xa levels, Elderly, Prevention, Enoxaparin, Low molecular weight heparin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin 20 mg
Arm Type
Active Comparator
Arm Title
Enoxaparin 30 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Enoxaparin 20Mg/0.2mL Prefilled Syringe
Intervention Description
Enoxaparin 20mg subcutaneously once daily
Intervention Type
Drug
Intervention Name(s)
Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml
Intervention Description
Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered
Primary Outcome Measure Information:
Title
Peak anti-Xa levels
Description
Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given
Time Frame
Day 3 of thromboprophylaxis
Secondary Outcome Measure Information:
Title
Trough anti-xa levels
Description
Trough anti-Xa levels, drawn right before the third enoxaparin dose is given
Time Frame
Day 3 of thromboprophylaxis
Title
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.
Title
Objectively confirmed symptomatic or asymptomatic venous thromboembolism (VTE) including both deep vein thrombosis (DVT) and or pulmonary embolism (PE).
Description
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).
Time Frame
Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, whichever comes first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nibal R Chamoun, PharmD
Organizational Affiliation
Lebanese American University
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAU Medical Center-Rizk Hospital
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31064405
Citation
Chamoun N, Ghanem H, Hachem A, Hariri E, Lteif C, Mansour H, Dimassi H, Zalloum R, Ghanem G. Evaluation of prophylactic dosages of Enoxaparin in non-surgical elderly patients with renal impairment. BMC Pharmacol Toxicol. 2019 May 7;20(1):27. doi: 10.1186/s40360-019-0308-8.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs