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

Who is this study for? Patients over 15 years with a higher risk of developing clots in their legs or lungs
What treatments are being studied? Enoxaparin Sodium Injection
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 100
Healthy Volunteers: f
View:

• Admitted patients requiring prophylactic dosing of enoxaparin (Lovenox)

• Admitted to the trauma or surgical service

• Age greater than 15 years

Locations
United States
Oregon
Oregon Health & Science University
RECRUITING
Portland
Contact Information
Primary
Laura Nguyen
nguyelau@ohsu.edu
Time Frame
Start Date: 2014-02
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 606
Treatments
Active_comparator: Enoxaparin Sodium Injection 30 mg BID
Subjects are randomized to receive 30 mg twice daily of enoxaparin.
Active_comparator: Enoxaparin Sodium Injection 40 mg QD
Subjects are randomized to receive 40 mg once daily of enoxaparin.
Sponsors
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov