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

This study has been withdrawn prior to enrollment.
(poor enrollment)
Sponsor:
Information provided by (Responsible Party):
Lisa Louwers, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01325779
First received: March 28, 2011
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Lower Extremity Deep Venous Thrombosis
Drug: heparin
Drug: enoxaparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Lower Extremity Deep Venous Thrombosis in the Surgical Intensive Care Unit: a Randomized Trial Comparing Subcutaneous Heparin and Subcutaneous Enoxaparin

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Development of lower extremity deep venous thrombosis [ Time Frame: hospital admission (day 1 ) to 3 months post discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events associated with use of subcutaneous heparin and enoxaparin [ Time Frame: hospital admission (day 1) through discharge ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2011
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325779

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Lisa Louwers
  More Information

No publications provided

Responsible Party: Lisa Louwers, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01325779     History of Changes
Other Study ID Numbers: HIC 2010-113
Study First Received: March 28, 2011
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
deep venous thrombosis
DVT
enoxaparin
heparin
surgical intensive care

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014