Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
242 participants
OBSERVATIONAL
2005-10-31
2007-08-31
Brief Summary
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Detailed Description
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HIT with thrombosis causes prolonged hospital length of stay and is associated with catastrophic outcomes such as extremity amputation as well as death. The fear of HIT has led to some proposals to minimize hospital use of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) and to substitute other anticoagulants that have not been reported to cause HIT. Therefore, the frequency of confirmed HIT and the frequency of determining whether UFH or LMWH is the causative agent urgently require further investigation.
At BWH, we have placed patient safety at a premium. We have a Patient Safety Committee and a Patient Safety Officer. HIT has been identified as one of the primary problems requiring urgent policy decisions. Consequently, we have formed a multi-disciplinary team of physicians, pharmacists, nurses and physician's assistants to improve safe medication practices for patients receiving anticoagulation.
Our primary objectives are to establish an HIT registry which will provide information on:
1. Incidence of HIT associated with UFH and LMWH
2. Outcomes of patients with HIT
3. Adverse events associated with alternative anticoagulants used to treat HIT
We will obtain data with respect to: Drug, Dose, Route of administration, Duration of therapy, Platelet count, Platelet nadir, Co-morbidities (Coronary Artery Disease, Diabetes Mellitus, Myocardial Infarction, Hypertension, Pulmonary Disease, Chronic Renal Failure, Malignancy, Liver Disease, Surgery, Sepsis), Baseline characteristics (Age, Sex, Weight), Pregnancy status, Serum Creatinine, AST, ALT, Hematocrit, Hemoglobin, Venous and Arterial Thrombotic events (DVT, PE, CVC), 30-day mortality rate, alternative anticoagulant therapy, and duration of therapy.
Time and Method of Data Collection:
Chart Review for the duration of hospitalization: Hemorrhagic event, Thrombotic events, and 30-day Mortality Rate.
Conditions
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Study Design
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RETROSPECTIVE
Study Groups
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HIT Patients
Patients at Brigham and Women's Hospital diagnosed with Heparin Induced Thrombocytopenia.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Brigham and Women's Hospital
OTHER
Responsible Party
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Brigham and Women's Hospital
Principal Investigators
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Samuel Z. Goldhaber, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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Baroletti SA, Goldhaber SZ. Heparin-induced thrombocytopenia. Circulation. 2006 Aug 22;114(8):e355-6. doi: 10.1161/CIRCULATIONAHA.106.632653. No abstract available.
Related Links
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North American Thrombosis Forum
Other Identifiers
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2005-P-001941
Identifier Type: -
Identifier Source: org_study_id
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