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Heparin Antibodies in Intensive Care Unit Patients (HAICU)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00283322
First received: January 25, 2006
Last updated: December 3, 2007
Last verified: December 2007
History of Changes
  Purpose

Intensive care unit patients have multiple risk factors for venous thromboembolism. Venous thromboembolism leads to significant morbidity and can be fatal. Unfractionated heparin and low molecular weight heparin are commonly used to prevent venous thromboembolism. Heparin induced thrombocytopenia, an untoward consequence of exposure to heparin, is an immune disorder that may develop in patients treated with heparin products. Determining the prevalence of heparin induced thrombocytopenia and its relationship to preventive and therapeutic heparin and low molecular weight heparin will help clinicians more appropriately choose methods of venous thromboembolism prophylaxis and treatment in the critically ill, ICU population.

The objective of this study is to determine the prevalence of heparin-induced antibodies on admission to the ICU and the development of new heparin-antibodies during the first week of hospitalization.


Condition Intervention
Heparin-Induced Thrombocytopenia
 Other: blood samples (2)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heparin Antibodies in Intensive Care Unit Patients (HAICU)

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Biospecimen Retention:   Samples Without DNA

Plasma. Patients consented for use to look for heparin antibodies in this study only.


Enrollment: 185
Study Start Date: November 2004
Study Completion Date: May 2006
Groups/Cohorts Assigned Interventions
Medical ICU patients
Patients admitted to a medical intensive care unit
 Other: blood samples (2)
Two blood samples were obtained from patients and tested for heparin antibodies.
Surgical ICU patients
Patients admitted to a surgical-trauma intensive care unit
 Other: blood samples (2)
Two blood samples were obtained from patients and tested for heparin antibodies.
Neuro ICU patients
Patients admitted to a neuro-trauma intensive care unit
 Other: blood samples (2)
Two blood samples were obtained from patients and tested for heparin antibodies.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive consenting patients admitted to neurotrauma, surgical-trauma or medical intensive care unit meeting enrollment criteria.

Criteria

Inclusion Criteria:

  • Adult patients (> 18 years of age) admitted to the

    • Neuro-trauma intensive care unit (NTICU)
    • Shock-trauma intensive care unit (STICU) or
    • Medical intensive care unit (MICU).
  • Completed informed consent process.

Exclusion Criteria:

  • Admitted to ICU for short-term observation or expected hospital length of stay of less than 5 days
  • Undergoing or planned plasmaphoresis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283322

Locations
United States, Florida
Florida Hospital Center for Hemostasis & Thrombosis (Laboratory)
Orlando, Florida, United States, 32804
United States, Texas
UT-Houston/Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
GlaxoSmithKline
Investigators
Principal Investigator: Robert L Levine, MD The University of Texas, Houston
  More Information

No publications provided

Responsible Party: Robert L. Levine, MD, The University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier: NCT00283322     History of Changes
Other Study ID Numbers: HSC-MS-04-0312, HAICU
Study First Received: January 25, 2006
Last Updated: December 3, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Heparin Induced Thrombocytopenia
HIT
HITT
Thrombosis
Thromboembolism

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Antibodies
Calcium heparin
Heparin
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013