Comparison of Subcutaneous Heparin and Enoxaparin for Deep Venous Thrombosis (DVT) Prophylaxis in Surgical Intensive Care Patients
Primary Purpose
Lower Extremity Deep Venous Thrombosis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
heparin
enoxaparin
Sponsored by
About this trial
This is an interventional prevention trial for Lower Extremity Deep Venous Thrombosis focused on measuring deep venous thrombosis, DVT, enoxaparin, heparin, surgical intensive care
Eligibility Criteria
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
Sites / Locations
- William Beaumont Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
subcutaneous heparin
subcutaneous enoxaparin
Arm Description
Outcomes
Primary Outcome Measures
Development of lower extremity deep venous thrombosis
Secondary Outcome Measures
Adverse events associated with use of subcutaneous heparin and enoxaparin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01325779
Brief Title
Comparison of Subcutaneous Heparin and Enoxaparin for Deep Venous Thrombosis (DVT) Prophylaxis in Surgical Intensive Care Patients
Official Title
Prevention of Lower Extremity Deep Venous Thrombosis in the Surgical Intensive Care Unit: a Randomized Trial Comparing Subcutaneous Heparin and Subcutaneous Enoxaparin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Withdrawn
Why Stopped
poor enrollment
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisa Louwers
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Deep Venous Thrombosis
Keywords
deep venous thrombosis, DVT, enoxaparin, heparin, surgical intensive care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subcutaneous heparin
Arm Type
Active Comparator
Arm Title
subcutaneous enoxaparin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
heparin
Intervention Description
subcutaneous heparin 5000 units every 8 hours
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Intervention Description
subcutaneous enoxaparin 40 milligrams every 24 hours
Primary Outcome Measure Information:
Title
Development of lower extremity deep venous thrombosis
Time Frame
hospital admission (day 1 ) to 3 months post discharge
Secondary Outcome Measure Information:
Title
Adverse events associated with use of subcutaneous heparin and enoxaparin
Time Frame
hospital admission (day 1) through discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Subcutaneous Heparin and Enoxaparin for Deep Venous Thrombosis (DVT) Prophylaxis in Surgical Intensive Care Patients
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