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

Not Applicable

Withdrawn

• Conditions: Venous Thromboembolism
• Interventions: Drug: intravenous continuous infusion of heparin (IV UFH); Drug: Subcutaneous Heparin

• Registration Number: NCT02707263
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-14
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous continuous infusion of heparin (IV UFH)	intravenous continuous infusion of heparin (IV UFH)	Heparin will be administered intravenously.
Subcutaneous heparin	Subcutaneous Heparin	Heparin will be subcutaneously administered.

Primary Outcome Measures

Name	Time	Method
Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin	3 Days

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States