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Lovenox 30 mg Twice Daily (BID) Versus 40 mg Once Daily (QD)

Primary Purpose

Trauma, Surgery, Deep Vein Thrombosis (DVT)

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin Sodium Injection 30 mg BID
Enoxaparin Sodium Injection 40 mg QD
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trauma focused on measuring Trauma, Surgery, Enoxaparin, DVTs, Thromboembolic events

Eligibility Criteria

15 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admitted patients requiring prophylactic dosing of enoxaparin (Lovenox)
  • Admitted to the trauma or surgical service
  • Age greater than 15 years

Exclusion Criteria:

  • Unable to obtain consent from patient or authorized representative
  • Presence of intracranial hemorrhage
  • Receiving therapeutic dose of enoxaparin (Lovenox)
  • Receiving other forms of anticoagulation
  • Presence of renal failure requiring non-standard dosing regimen

Sites / Locations

  • Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enoxaparin Sodium Injection 30 mg BID

Enoxaparin Sodium Injection 40 mg QD

Arm Description

Subjects are randomized to receive 30 mg twice daily of enoxaparin.

Subjects are randomized to receive 40 mg once daily of enoxaparin.

Outcomes

Primary Outcome Measures

Thromboembolic events
Daily monitoring per standard of care for the development of thromboembolic events.

Secondary Outcome Measures

Increase in bleeding complications
Daily monitoring for an increase in bleeding complications due to study drug dose and regime.

Full Information

First Posted
May 21, 2014
Last Updated
April 14, 2022
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT02342444
Brief Title
Lovenox 30 mg Twice Daily (BID) Versus 40 mg Once Daily (QD)
Official Title
A Prospective Randomized Trial Comparing Two Standard Doses of Enoxaparin for the Prevention of Thromboembolism in Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2014 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many times enoxaparin (or Lovenox) is given to patients who are at a higher risk of developing clots in their legs or lungs. There are two standard doses of enoxaparin that are recommended by the drug companies. These two doses have never been directly compared in trauma, general, and vascular surgery patients. The purposes of this study are: to compare the development of blood clots in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily of enoxaparin. to determine if there is higher risk of bleeding complications in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily. Patients enrolled into the study will be randomized to receive enoxaparin, 30mg twice daily or enoxaparin, 40mg once daily. Patients will then be monitored for signs and symptoms of blood clots. At the time of discharge (or before, if medically indicated), an ultrasound test will be performed to look for blood clots in the patient's legs. The investigators will compare incidence of blood clots formed between the 2 groups of patients to determine if one dose of enoxaparin relates to a lower rate of blood clots in critically ill patients. The investigators will also compare the incidence of bleeding complications between the 2 groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Surgery, Deep Vein Thrombosis (DVT), Thromboembolic Events
Keywords
Trauma, Surgery, Enoxaparin, DVTs, Thromboembolic events

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
606 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin Sodium Injection 30 mg BID
Arm Type
Active Comparator
Arm Description
Subjects are randomized to receive 30 mg twice daily of enoxaparin.
Arm Title
Enoxaparin Sodium Injection 40 mg QD
Arm Type
Active Comparator
Arm Description
Subjects are randomized to receive 40 mg once daily of enoxaparin.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin Sodium Injection 30 mg BID
Other Intervention Name(s)
Lovenox
Intervention Type
Drug
Intervention Name(s)
Enoxaparin Sodium Injection 40 mg QD
Other Intervention Name(s)
Lovenox
Primary Outcome Measure Information:
Title
Thromboembolic events
Description
Daily monitoring per standard of care for the development of thromboembolic events.
Time Frame
Daily, up to Day 90
Secondary Outcome Measure Information:
Title
Increase in bleeding complications
Description
Daily monitoring for an increase in bleeding complications due to study drug dose and regime.
Time Frame
Daily, up to Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admitted patients requiring prophylactic dosing of enoxaparin (Lovenox) Admitted to the trauma or surgical service Age greater than 15 years Exclusion Criteria: Unable to obtain consent from patient or authorized representative Presence of intracranial hemorrhage Receiving therapeutic dose of enoxaparin (Lovenox) Receiving other forms of anticoagulation Presence of renal failure requiring non-standard dosing regimen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Underwood, MS
Phone
503 494-8481
Email
underwos@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Hamilton, BS
Email
hamilthe@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin A Schreiber, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Underwood, MS
Phone
503-494-8481
Email
underwos@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Mackenzie Cook, MD
First Name & Middle Initial & Last Name & Degree
Philbert Van, MD

12. IPD Sharing Statement

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Lovenox 30 mg Twice Daily (BID) Versus 40 mg Once Daily (QD)

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