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

NCT ID: NCT02707263

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-04-30

Brief Summary

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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

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intravenous continuous infusion of heparin (IV UFH)

Heparin will be administered intravenously.

Group Type ACTIVE_COMPARATOR

intravenous continuous infusion of heparin (IV UFH)

Intervention Type DRUG

Subcutaneous heparin

Heparin will be subcutaneously administered.

Group Type ACTIVE_COMPARATOR

Subcutaneous Heparin

Intervention Type DRUG

Interventions

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intravenous continuous infusion of heparin (IV UFH)

Intervention Type DRUG

Subcutaneous Heparin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Papadopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-01051

Identifier Type: -

Identifier Source: org_study_id

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