Heparin-Induced Thrombocytopenia Registry (HIT)
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|ClinicalTrials.gov Identifier: NCT00456326|
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : February 18, 2008
|Condition or disease|
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:
- Incidence of HIT associated with UFH and LMWH
- Outcomes of patients with HIT
- 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.
|Study Type :||Observational|
|Actual Enrollment :||242 participants|
|Official Title:||A 3 Year Retrospective Heparin Induced Thrombocytopenia Registry (HIT) at Brigham and Women's Hospital.|
|Study Start Date :||October 2005|
|Actual Study Completion Date :||August 2007|
Patients at Brigham and Women's Hospital diagnosed with Heparin Induced Thrombocytopenia.
- Incidence of HIT associated with UFH and LMWH [ Time Frame: 30 Days ]
- Outcomes of patients with HIT [ Time Frame: 30 Days ]
- Adverse events associated with alternative anticoagulants used to treat HIT [ Time Frame: 30 Days ]
- Mortality [ Time Frame: 30 Days ]
- Hemorrhagic Events [ Time Frame: 30 Days ]
- Thrombotic Events [ Time Frame: 30 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456326
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Samuel Z. Goldhaber, MD||Brigham and Women's Hospital|