Using Intravenous Heparin Versus Standard of Care Subcutaneous Heparin to Prevent Clots After Surgery
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

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.
    

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.
    

Intervention name(s): low dose intravenous heparin (LDIVH); Heparin
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 5000 units given subcutaneously three times a day until ICU discharge or a maximum of 28 days
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: venous thrombosis; heparin; pulmonary embolism; ICU