Heparin Induced Thrombocytopenia: Pharmacoeconomics
This study has been completed.
Sponsor:
Brigham and Women's Hospital
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
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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 May 22, 2013