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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02707263
Recruitment Status : Withdrawn
First Posted : March 14, 2016
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: intravenous continuous infusion of heparin (IV UFH) Drug: Subcutaneous Heparin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients
Study Start Date : March 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Intravenous continuous infusion of heparin (IV UFH)
Heparin will be administered intravenously.
Drug: intravenous continuous infusion of heparin (IV UFH)
Active Comparator: Subcutaneous heparin
Heparin will be subcutaneously administered.
Drug: Subcutaneous Heparin



Primary Outcome Measures :
  1. Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin [ Time Frame: 3 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707263


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: John Papadopoulos, MD New York University Medical School

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02707263    
Other Study ID Numbers: 15-01051
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Keywords provided by NYU Langone Health:
heparin
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action