Venous Thromboembolism
Conditions
Keywords
heparin
Brief summary
The primary purpose of this study is to demonstrate that a continuous infusion of intravenous (IV) heparin (UFH) for Venous thromboembolism (VTE) prophylaxis will restore prophylactic levels of heparin in high-risk critically ill medical patients as compared with guideline recommended subcutaneous heparin. Antifactor Xa assay, a laboratory test to measure the anticoagulant activity of heparin, or the ability of heparin to thin the blood, will be used to demonstrate that Intravenous administration is more effective.
Interventions
DRUGintravenous continuous infusion of heparin (IV UFH)
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admission to the medical ICU (MICU) * High-risk for Venous Thromboembolism (VTE) ≥ 1 of the following: * Body Mass Index (BMI) ≥ 30 kg/m2 * Personal or family history of VTE * Receiving vasopressors
Exclusion criteria
* Indication for therapeutic anticoagulation * Evidence of deep vein thrombosis (DVT) on ultrasonography at admission * Indwelling intrathecal, epidural, or other indwelling deep catheters * Recent (\< 3 months) International Society of Thrombosis and Haemostasis (ISTH) major bleeding13 * Recent (\< 3 months) major trauma * Recent (\< 3 months) neurosurgery or orthopedic surgery Pregnancy * Contraindication to heparin or heparin products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin | 3 Days |
Countries
United States
Outcome results
None listed