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Trial record 57 of 990 for:    Heparin sodium

Using Intravenous Heparin Versus Standard of Care Subcutaneous Heparin to Prevent Clots After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01608906
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : May 20, 2014
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study plans to learn more about what is the best treatment to prevent blood clots in patients in intensive care units (ICU's). The investigators know that patients who are in ICU's have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous as the clot may move into the lungs. To prevent this, the standard treatment is to give low dose heparin subcutaneously 3 times a day (usually 5000 units at each dose). In this study the investigators are randomizing patients to receive either standard of care or low dose intravenous heparin in a continuous infusion.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Drug: low dose intravenous heparin (LDIVH) Drug: Heparin Not Applicable

Detailed Description:
Macro- and micro-thrombosis both contribute significantly to morbidity and mortality in the surgical intensive care unit. Pulmonary embolism (PE) is a common and preventable cause of death in critically ill patients, with a mortality rate of up to 10%. Up to 95% of cases of PE originate from deep venous thrombosis (DVT). There are multiple pharmacologic and non-pharmacologic methods of DVT prophylaxis.The current standard of care in thromboprophylaxis in the surgical intensive care unit (SICU) at the University of Colorado Hospital is low-dose subcutaneous heparin (SCH). However, there is little evidence that this is the optimal prophylactic treatment. In fact, a database search of ICD-9 diagnoses made in 2005 suggests that the incidence of DVT in SICU patients, the majority who receive subcutaneous heparin, is approximately 7%. Surgical ICU patients are at high risk of developing DVT during their hospital stay and likely need more aggressive anticoagulation. Intravenous heparin, given at a low dose and titrated to a measurable endpoint PTT (partial thromboplastin time), may offer several benefits over the current standard of care, subcutaneous heparin. This method of treatment would offer more aggressive anticoagulation and allow dosage to be adjusted frequently based on each patient's changing coagulation status.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Low Dose Intravenous Heparin in Preventing Thromboembolism in the SICU.
Study Start Date : May 2007
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: continuous low dose intravenous heparin infusion
titrated to a PTT of 40-45
Drug: low dose intravenous heparin (LDIVH)
The LDIVH (experimental) group will receive a continuous heparin drip titrated to a prothrombin time (PTT) of 40-45. LDIVH subjects will have PTT tested within 24 hours prior to initiation of LDIVH. In addition, these subjects would continue to have a PTT tested every 6 hours until the PTT value falls between 40-45. All LDIVH subjects will have PTT values measured at least daily. This will continue until ICU discharge or a maximum of 28 days.

Active Comparator: subcutanous heparin 5000 units 3 times/day
standard of care
Drug: Heparin
5000 units given subcutaneously three times a day until ICU discharge or a maximum of 28 days

Primary Outcome Measures :
  1. development of DVT (deep vein thrombosis) [ Time Frame: from start of study intervention to 6 months ]
    In the first 70 patients, screening for DVT by ultrasound will occur on study days 0 and 5. After day 5 and for all remaining subjects, DVT will be diagnosed according to standard of care by the attending physician. Incidences of new DVT will be recorded daily until the patient is discharged from the hospital, or for a maximum of 28 days. DVT diagnosis will also be collected at 6 months from the primary care physician's office or the patient's household.

Secondary Outcome Measures :
  1. development of PE's; sepsis [ Time Frame: up to 28 days post study intervention start ]
    Secondary endpoints to be monitored for a maximum of 28 days, include: (1) total number of patients not developing PE; (2) total number of patients not developing sepsis; and (3) total number of patients not developing catheter-associated sepsis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A signed informed consent;
  • Age between 18 and 80 years
  • The patient is admitted to the surgical intensive care unit at the University of Colorado Hospital

Exclusion Criteria:

  • Predicated SICU stay less than 5 days;
  • Pregnancy;
  • Breast feeding;
  • Initial platelet count < 30,000;
  • Currently eligible for treatment of thromboembolism;
  • Prior organ transplant;
  • Cardiopulmonary bypass within previous 30 days;
  • Advanced directive precluding participation;
  • Already receiving pharmacologic agent for DVT prophylaxis;
  • Prior diagnosis of heparin-induced thrombocytopenia;
  • Heparin allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01608906

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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
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Principal Investigator: Sara Cheng, MD; PhD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver Identifier: NCT01608906     History of Changes
Other Study ID Numbers: 06-0854
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Keywords provided by University of Colorado, Denver:
venous thrombosis
pulmonary embolism

Additional relevant MeSH terms:
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Calcium heparin
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action