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Trial record 6 of 6 for:    "Thrombocytopenia" | "Dalteparin"

Heparin-Induced Thrombocytopenia Registry (HIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00456326
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : February 18, 2008
Mitsubishi Tanabe Pharma Corporation
Information provided by:
Brigham and Women's Hospital

Brief Summary:
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 or disease
Heparin-Induced Thrombocytopenia

Detailed Description:

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:

  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.

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Study Type : Observational
Actual Enrollment : 242 participants
Time Perspective: Retrospective
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

HIT Patients
Patients at Brigham and Women's Hospital diagnosed with Heparin Induced Thrombocytopenia.

Primary Outcome Measures :
  1. Incidence of HIT associated with UFH and LMWH [ Time Frame: 30 Days ]
  2. Outcomes of patients with HIT [ Time Frame: 30 Days ]
  3. Adverse events associated with alternative anticoagulants used to treat HIT [ Time Frame: 30 Days ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 Days ]
  2. Hemorrhagic Events [ Time Frame: 30 Days ]
  3. Thrombotic Events [ Time Frame: 30 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Heparin Induced Thrombocytopenia
All patients hospitalized at BWH who have a PF4-Positive antibody test

Information from the National Library of Medicine

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 identifier (NCT number): NCT00456326

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Mitsubishi Tanabe Pharma Corporation
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Principal Investigator: Samuel Z. Goldhaber, MD Brigham and Women's Hospital

Additional Information:
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Responsible Party: Samuel Z. Goldhaber, MD, Brigham and Women's Hospital Identifier: NCT00456326     History of Changes
Other Study ID Numbers: 2005-P-001941
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: February 2008
Keywords provided by Brigham and Women's Hospital:
Unfractionated Heparin
Low Molecular Weight Heparin
Venous Thrombosis
Pulmonary Embolism
Additional relevant MeSH terms:
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Blood Platelet Disorders
Hematologic Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action