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

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NYU Langone Health

Status

Withdrawn

Conditions

Venous Thromboembolism

Treatments

Drug: Subcutaneous Heparin
Drug: intravenous continuous infusion of heparin (IV UFH)

Study type

Interventional

Funder types

Other

Identifiers

NCT02707263
15-01051

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

Intravenous continuous infusion of heparin (IV UFH)
Active Comparator group
Description:
Heparin will be administered intravenously.
Treatment:
Drug: intravenous continuous infusion of heparin (IV UFH)
Subcutaneous heparin
Active Comparator group
Description:
Heparin will be subcutaneously administered.
Treatment:
Drug: Subcutaneous Heparin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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