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Heparin-Induced Thrombocytopenia Registry

A 3 Year Retrospective Heparin Induced Thrombocytopenia Registry (HIT) at Brigham and Women's Hospital.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00456326
Acronym
HIT
Enrollment
242
Registered
2007-04-04
Start date
2005-10-31
Completion date
2007-08-31
Last updated
2008-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heparin-Induced Thrombocytopenia

Keywords

Heparin, Unfractionated Heparin, Low Molecular Weight Heparin, Anticoagulation, Thrombocytopenia, Thrombosis, Venous Thrombosis, Pulmonary Embolism

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.

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.

Interventions

None listed

Sponsors

Tanabe Pharma Corporation
CollaboratorINDUSTRY
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

All patients hospitalized at BWH who have a PF4-Positive antibody test

Design outcomes

Primary

MeasureTime frame
Incidence of HIT associated with UFH and LMWH30 Days
Outcomes of patients with HIT30 Days
Adverse events associated with alternative anticoagulants used to treat HIT30 Days

Secondary

MeasureTime frame
Mortality30 Days
Hemorrhagic Events30 Days
Thrombotic Events30 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026