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

• Status: Withdrawn
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Calcium heparin; Heparin

Criteria

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