Comparison of Subcutaneous Heparin and Enoxaparin for Deep Venous Thrombosis (DVT) Prophylaxis in Surgical Intensive Care Patients

Prevention of Lower Extremity Deep Venous Thrombosis in the Surgical Intensive Care Unit: a Randomized Trial Comparing Subcutaneous Heparin and Subcutaneous Enoxaparin

Study hypothesis: Subcutaneous enoxaparin is more effective than subcutaneous heparin in preventing the development of DVT in the general surgical intensive care unit population.

Hospitalized patients are at increased risk for the development of blood clots in the legs, known as deep venous thrombosis (DVT). Surgical patients are in a higher risk category than the general hospital population due to a number of factors including undergoing surgery and increased risk of immobility. The highest risk patients are in the surgical intensive care unit, where their surgical risks for blood clots are combined with issues such as sepsis, acquired blood clotting disorders, and increasing age, each of which are factors that contribute to the risk of blood clot development. 1. Patients who develop these blood clots (DVTs) are at risk for chronic leg swelling, pain, and in some cases, chronic ulcer development on the leg. In the worst case scenario, these blood clots can break away and migrate to the lungs where they cause a pulmonary embolism (PE), a clot in the lungs that can cause significant breathing difficulty requiring intubation and mechanical ventilation, and in some cases, death.

According to recent research, DVTs account for over 200,000 patient deaths each year nationwide. 2. A large amount of data has supported the use of medication called heparin or enoxaparin in low doses to prevent these blood clots from forming while in the hospital. Both of these medications are considered standard of care for use patients considered moderate and high risk for the development of DVT. 3. While both of these medications have been shown to significantly reduce the occurrence of DVT in appropriate doses, 4. there has never been a direct comparison of the two medications in the highest-risk population of the surgical intensive care unit. Our own preliminary data suggests patients may have a lower incidence of DVTs with the use of enoxaparin versus heparin. Part of the reason for this may be the requirement for three times daily dosing of the heparin compared to once daily dosing for enoxaparin. There may also be some inherent differences in the efficacy of the medications themselves.

Study Overview

• Status: Withdrawn
• Conditions: Lower Extremity Deep Venous Thrombosis
• Intervention / Treatment: Drug: heparin; Drug: enoxaparin

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age > 18 years old
• admission to the surgical intensive care unit
• admitting physician is a surgeon or patient is status-post a surgical procedure

Exclusion Criteria:

• age < 18 years old
• inability to obtain informed consent from patient or legal representative within 24 hours of SICU admission
• patient admitted to neurosurgery or status-post a neurosurgical procedure
• patient status-post an orthopedic procedure
• patient admitted with a primary diagnosis of trauma
• patient with a history of a bleeding disorder or other contraindication to even low-dose anticoagulation medicine including a history of heparin-induced thrombocytopenia verified with a positive serotonin-release assay or have a high clinical suspicion of new onset heparin-induced thrombocytopenia resulting in the discontinuation of heparin or enoxaparin by the treating physicians
• patients on current full anticoagulation medications including a heparin drip or warfarin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: subcutaneous heparin	Drug: heparin; subcutaneous heparin 5000 units every 8 hours
Active Comparator: subcutaneous enoxaparin	Drug: enoxaparin; subcutaneous enoxaparin 40 milligrams every 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Development of lower extremity deep venous thrombosis	hospital admission (day 1 ) to 3 months post discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events associated with use of subcutaneous heparin and enoxaparin	hospital admission (day 1) through discharge

Collaborators and Investigators

• Sponsor: Lisa Louwers

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 28, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2013
• Last Update Submitted That Met QC Criteria: May 17, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: heparin; deep venous thrombosis; DVT; enoxaparin; surgical intensive care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Enoxaparin
• Other Study ID Numbers: HIC 2010-113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No