Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
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Started Mar 2016
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 27, 2017
April 1, 2017
1.1 years
March 1, 2016
April 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin
3 Days
Study Arms (2)
Intravenous continuous infusion of heparin (IV UFH)
ACTIVE COMPARATORHeparin will be administered intravenously.
Subcutaneous heparin
ACTIVE COMPARATORHeparin will be subcutaneously administered.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Papadopoulos, MD
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2016
First Posted
March 14, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
April 27, 2017
Record last verified: 2017-04