Recruiting

Lovenox 30 mg vs. Lovenox 40 mg

Sponsor:

Oregon Health and Science University

Code:

NCT02342444

Conditions

Trauma

Surgery

Deep Vein Thrombosis (DVT)

Thromboembolic Events

Eligibility Criteria

Sex: All

Age: 15 - 70+

Healthy Volunteers: Not accepted

Interventions

Enoxaparin Sodium Injection 30 mg BID

Enoxaparin Sodium Injection 40 mg QD

Study Details

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. 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.

Conditions

Trauma

Surgery

Deep Vein Thrombosis (DVT)

Thromboembolic Events

Study ID

NCT02342444

Start date

Feb, 2014

Status verified date

Apr, 2024

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

606 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Enoxaparin Sodium Injection 30 mg BID

Enoxaparin Sodium Injection 40 mg QD

Primary outcome measure

  • Thromboembolic events [ Time Frame: Daily, up to Day 90 ]

Central Contacts and Locations

Central contacts

Laura Nguyen

nguyelau@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Laura Nguyen

nguyelau@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 3, 2024

Last verified

Apr, 2024

Keywords

  • Trauma
  • Surgery
  • Enoxaparin
  • DVTs
  • Thromboembolic events

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-04-03.