Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients

NYU Langone Health

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Venous Thromboembolism

Interventions

intravenous continuous infusion of heparin (IV UFH)DRUG

Subcutaneous HeparinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin

Time frame: 3 Days

Data from ClinicalTrials.gov

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