Venous Thrombosis
Conditions
Keywords
venous thrombosis, heparin, pulmonary embolism, ICU
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.
Interventions
DRUGlow 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.
DRUGHeparin
5000 units given subcutaneously three times a day until ICU discharge or a maximum of 28 days
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of DVT (Deep Vein Thrombosis) | 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
| Measure | Time frame | Description |
|---|---|---|
| Development of PE's; Sepsis | 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. |
Countries
United States
Participant flow
Pre-assignment details
PI left the university in 2013. Numerous attempts were made to contact the PI and study team members, but efforts were unsuccessful. Arms are combined because no data is available regarding how participants were assigned to each study arm.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Treatment: titrated to a PTT of 40-45. 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.
Control: Standard of Care. | 152 |
| Total | 152 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 152 Participants |
| Region of Enrollment United States | 152 participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 152 |
| other Total, other adverse events | 0 / 152 |
| serious Total, serious adverse events | 0 / 152 |
Outcome results
Primary
Development of DVT (Deep Vein Thrombosis)
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.
Time frame: from start of study intervention to 6 months
Population: PI left the university in 2013. Numerous attempts were made to contact the PI and study team members, but efforts were unsuccessful. No outcome measure data is available
Secondary
Development of PE's; Sepsis
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.
Time frame: up to 28 days post study intervention start
Population: PI left the university in 2013. Numerous attempts were made to contact the PI and study team members, but efforts were unsuccessful. No outcome measure data is available