Venous ThromboembolismNCT02707263
Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients
A study testing intravenous continuous infusion of heparin (IV UFH) and Subcutaneous Heparin in people with Venous Thromboembolism, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- intravenous continuous infusion of heparin (IV UFH) and Subcutaneous Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Venous Thromboembolism
- Being tested
- intravenous continuous infusion of heparin (IV UFH), Subcutaneous Heparin
- Keywords
- heparin
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous continuous infusion of heparin (IV UFH)Drug
Subcutaneous HeparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous continuous infusion of heparin (IV UFH) | Active comparator | Heparin will be administered intravenously. Receives: Drug: intravenous continuous infusion of heparin (IV UFH) |
| Subcutaneous heparin | Active comparator | Heparin will be subcutaneously administered. Receives: Drug: Subcutaneous Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Papadopoulos, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707263
- Sponsor's protocol ID
- 15-01051
- Status last verified
- Apr 2017
- First submitted
- 1 Mar 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02707263
- Acronym / sponsor ID
- 15-01051
- Conditions
- Venous Thromboembolism
- Keywords
- heparin
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous continuous infusion of heparin (IV UFH) | Active comparator | Drug: intravenous continuous infusion of heparin (IV UFH)Heparin will be administered intravenously. |
| Subcutaneous heparin | Active comparator | Drug: Subcutaneous HeparinHeparin will be subcutaneously administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous continuous infusion of heparin (IV UFH) | Drug | Intravenous continuous infusion of heparin (IV UFH) |
| Subcutaneous Heparin | Drug | Subcutaneous heparin |
Primary outcome
Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin
Time frame: 3 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Papadopoulos, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous continuous infusion of heparin (IV UFH) and Subcutaneous Heparin in people with Venous Thromboembolism, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin (time frame: 3 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.