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

Primary Purpose

Venous Thromboembolism

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
intravenous continuous infusion of heparin (IV UFH)
Subcutaneous Heparin
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring heparin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intravenous continuous infusion of heparin (IV UFH)

Subcutaneous heparin

Arm Description

Heparin will be administered intravenously.

Heparin will be subcutaneously administered.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 1, 2016
Last Updated
April 25, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02707263
Brief Title
Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients
Official Title
Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
heparin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous continuous infusion of heparin (IV UFH)
Arm Type
Active Comparator
Arm Description
Heparin will be administered intravenously.
Arm Title
Subcutaneous heparin
Arm Type
Active Comparator
Arm Description
Heparin will be subcutaneously administered.
Intervention Type
Drug
Intervention Name(s)
intravenous continuous infusion of heparin (IV UFH)
Intervention Type
Drug
Intervention Name(s)
Subcutaneous Heparin
Primary Outcome Measure Information:
Title
Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin
Time Frame
3 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Papadopoulos, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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