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Study 15 of 168 for search of: | "Thrombocytopenia" |
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Sponsors and Collaborators: |
Brigham and Women's Hospital Mitsubishi Tanabe Pharma Corporation |
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Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00456326 |
The purpose of the Heparin Induced Thrombocytopenia Registry is to explore the frequency of heparin-induced thrombocytopenia (HIT) at Brigham and Women's Hospital and to assess its mortality rate. Retrospective 3 years, looking forward prospectively.
Condition |
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Heparin-Induced Thrombocytopenia |
Study Type: | Observational |
Study Design: | Retrospective |
Official Title: | A 3 Year Retrospective Heparin Induced Thrombocytopenia Registry (HIT) at Brigham and Women's Hospital. |
Enrollment: | 242 |
Study Start Date: | October 2005 |
Study Completion Date: | August 2007 |
Groups/Cohorts |
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HIT Patients
Patients at Brigham and Women's Hospital diagnosed with Heparin Induced Thrombocytopenia.
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Heparin-induced thrombocytopenia (HIT) is an immune-mediated adverse drug reaction with potentially fatal complications of venous and arterial thrombosis.
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:
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients diagnosed with Heparin Induced Thrombocytopenia
All patients hospitalized at BWH who have a PF4-Positive antibody test
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Samuel Z. Goldhaber, MD | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital ( Samuel Z. Goldhaber, MD ) |
Study ID Numbers: | 2005-P-001941 |
Study First Received: | April 2, 2007 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00456326 |
Health Authority: | United States: Institutional Review Board |
Heparin Unfractionated Heparin Low Molecular Weight Heparin Anticoagulation |
Thrombocytopenia Thrombosis Venous Thrombosis Pulmonary Embolism |
Pulmonary Embolism Hematologic Diseases Blood Platelet Disorders Heparin, Low-Molecular-Weight Thrombosis Calcium heparin Body Weight |
Thrombocytopathy Thrombocytopenia Embolism Heparin-induced thrombocytopenia Venous Thrombosis Heparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |