Clinical trial NCT01608906: Using Intravenous Heparin Versus Standard of Care Subcutaneous Heparin to Prevent Clots After Surgery
Official title: Efficacy of Low Dose Intravenous Heparin in Preventing Thromboembolism in the SICU.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thrombosis
Keywords: venous thrombosis
heparin
pulmonary embolism
ICU
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of DVT (Deep Vein Thrombosis)
timeFrame: from start of study intervention to 6 months
Secondary outcomes:
measure: Development of PE's; Sepsis
timeFrame: up to 28 days post study intervention start
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sara Cheng, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: