Heparin Induced Thrombocytopenia: Pharmacoeconomics

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00456001
First received: April 2, 2007
Last updated: February 26, 2009
Last verified: February 2009
  Purpose

Patients at BWH receiving unfractionated heparin or enoxaparin who subsequently develop heparin induced thrombocytopenia will be identified via a computer generated report designed for the purposes of this study.

Subsequently, we will compare the heparin induced thrombocytopenia rates associated with heparin and low molecular weight heparin usage as well as evaluate the economic and long-term clinical burden of heparin induced thrombocytopenia.


Condition
Heparin Induced Thrombocytopenia (HIT)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study to Compare the Heparin Induced Thrombocytopenia Rates Associated With Heparin and Low Molecular Weight Heparin Usage as Well as Evaluate the Economic and Long-Term Clinical Burden of Heparin Induced Thrombocytopenia.

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Clotting and Bleeding Complications [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: July 2006
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients hospitalized at BWH who have a PF4-Positive antibody test

Criteria

All patients hospitalized at BWH who have a PF4-Positive antibody test

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456001

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Sanofi
Investigators
Principal Investigator: Samuel Z. Goldhaber, MD Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Samuel Z. Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00456001     History of Changes
Other Study ID Numbers: 2006-P-001982
Study First Received: April 2, 2007
Last Updated: February 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
heparin
low molecular weight heparin
enoxaparin
anticoagulation
thrombosis
venous thrombosis
thromboembolism
pulmonary embolism
medication

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014