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

NCT02342444 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 8080
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 1

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:

1. 1.to compare the development of blood clots in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily of enoxaparin.
2. 2.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.

Conditions

Trauma; Surgery; Deep Vein Thrombosis (DVT); Thromboembolic Events

Keywords

Trauma; Surgery; Enoxaparin; DVTs; Thromboembolic events

Outcome Measures

Primary Outcomes (1)

• Thromboembolic events

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

  Daily, up to Day 90

Secondary Outcomes (1)

• Increase in bleeding complications

  Daily, up to Day 90

Study Arms (2)

Enoxaparin Sodium Injection 30 mg BID

ACTIVE COMPARATOR

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

Drug: Enoxaparin Sodium Injection 30 mg BID

Enoxaparin Sodium Injection 40 mg QD

ACTIVE COMPARATOR

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

Drug: Enoxaparin Sodium Injection 40 mg QD

Interventions

Enoxaparin Sodium Injection 30 mg BID DRUG

Also known as: Lovenox

Enoxaparin Sodium Injection 30 mg BID

Enoxaparin Sodium Injection 40 mg QD DRUG

Also known as: Lovenox

Enoxaparin Sodium Injection 40 mg QD

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Venous Thrombosis; Thromboembolism

Interventions

enoxaparin sodium; BID protein, human; Enoxaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Martin A Schreiber, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Nguyen

CONTACT

nguyelau@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chief of Trauma

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: January 21, 2015
• Study Start: February 1, 2014
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

US (1)