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

A Prospective Randomized Trial Comparing Two Standard Doses of Enoxaparin for the Prevention of Thromboembolism in Surgical Patients

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. 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. 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.

Study Overview

• Status: Recruiting
• Conditions: Trauma; Surgery; Deep Vein Thrombosis (DVT); Thromboembolic Events
• Intervention / Treatment: Drug: Enoxaparin Sodium Injection 30 mg BID; Drug: Enoxaparin Sodium Injection 40 mg QD

Detailed Description

This is a prospective randomized single center study in human subjects.

Initiation of enoxaparin thromboprophylaxis will be done by the treatment team. Patients admitted to the trauma service will be eligible for enrollment. Research staff will approach patients or their LARs for consent prior to or at the time enoxaparin is ordered. This will include patients with traumatic intracranial hemorrhage, after the consulting neurosurgical team and primary treatment team decide to initiate thromboprophylaxis. Once enrolled, the subject will be randomized to receive either 30 mg twice daily dosing or 40 mg daily dosing of enoxaparin. However, treatment team will be responsible for deciding when to start enoxaparin treatment. Patients who are discharged without receiving enoxaparin or are started on a non-standard or therapeutic dose will be withdrawn from the study. Patient characteristics: age, sex, body mass index (BMI), medical comorbidities, Acute Physiology and Chronic Health Evaluation II score (APACHE II), injuries, and operations will be collected, coded with a unique identification letter and number combination, and entered into a database.

All patients will undergo weekly ultrasound duplex examination of the lower extremities for the presence of deep venous thrombosis. Patients who develop symptoms of pulmonary embolism including acute shortness of breath and increased A-a gradient will undergo computed tomography angiography as part of their standard care. A bleeding complication will be defined as a known bleeding episode associated with hypotension (greater than 20 mmHG drop from baseline) and the need for blood transfusion.

Current practice at OHSU is for patients age 15 and above to be admitted to the adult trauma service, and are treated with the same standard of care as adults. Currently, there are no clear data stratifying the risk of VTE in this population compared to other age groups. Therefore, patients in this age range on the adult Trauma Service will be included in the study as they are treated in the same method as our adult patient population.

• Study Type: Interventional
• Enrollment (Estimated): 606
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Laura Nguyen; Email: nguyelau@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Laura Nguyen; Email: nguyelau@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enoxaparin Sodium Injection 30 mg BID; Subjects are randomized to receive 30 mg twice daily of enoxaparin.	Drug: Enoxaparin Sodium Injection 30 mg BID; Other Names: Lovenox
Active Comparator: Enoxaparin Sodium Injection 40 mg QD; Subjects are randomized to receive 40 mg once daily of enoxaparin.	Drug: Enoxaparin Sodium Injection 40 mg QD; Other Names: Lovenox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thromboembolic events	Daily monitoring per standard of care for the development of thromboembolic events.	Daily, up to Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in bleeding complications	Daily monitoring for an increase in bleeding complications due to study drug dose and regime.	Daily, up to Day 90

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Martin A Schreiber, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: January 14, 2015
• First Posted (Estimated): January 21, 2015

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Enoxaparin; Trauma; Thromboembolic events; DVTs
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: 8080

Drug and device information, study documents

• 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