HIT: Heparin-Induced Thrombocytopenia Registry

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00456326

Collaborator

Mitsubishi Tanabe Pharma Corporation (Industry)

242

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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:

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 Design

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 :

Oct 1, 2005

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
HIT Patients Patients at Brigham and Women's Hospital diagnosed with Heparin Induced Thrombocytopenia.

Outcome Measures

Primary Outcome Measures

Incidence of HIT associated with UFH and LMWH [30 Days]
Outcomes of patients with HIT [30 Days]
Adverse events associated with alternative anticoagulants used to treat HIT [30 Days]