Heparin-Induced Thrombocytopenia Registry (HIT)

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 242

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Heparin Induced Thrombocytopenia

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HIT Patients; Patients at Brigham and Women's Hospital diagnosed with Heparin Induced Thrombocytopenia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	30 Days
Hemorrhagic Events	30 Days
Thrombotic Events	30 Days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Mitsubishi Tanabe Pharma Corporation
• Investigators: Principal Investigator: Samuel Z. Goldhaber, MD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Baroletti SA, Goldhaber SZ. Heparin-induced thrombocytopenia. Circulation. 2006 Aug 22;114(8):e355-6. doi: 10.1161/CIRCULATIONAHA.106.632653. No abstract available.

Helpful Links

• North American Thrombosis Forum

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: April 2, 2007
• First Submitted That Met QC Criteria: April 3, 2007
• First Posted (Estimate): April 4, 2007

Study Record Updates

• Last Update Posted (Estimate): February 18, 2008
• Last Update Submitted That Met QC Criteria: February 12, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: Anticoagulation; Thrombosis; Heparin; Pulmonary Embolism; Low Molecular Weight Heparin; Thrombocytopenia; Unfractionated Heparin; Venous Thrombosis
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: 2005-P-001941