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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:5/5/2014
Start Date:May 2007
End Date:May 2014
Contact:Angela M Almagro, BSN
Email:angela.almagro@ucdenver.edu
Phone:303-724-3596

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Efficacy of Low Dose Intravenous Heparin in Preventing Thromboembolism in the SICU.

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.

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.

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
We found this trial at
1
site
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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