Heparin-Induced Thrombocytopenia Registry

Heparin-Induced Thrombocytopenia Clinical Trial

— HIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456326
• Other study ID #: 2005-P-001941
• Status: Completed
• Phase: N/A
• First received: April 2, 2007
• Last updated: February 12, 2008
• Start date: October 2005
• Est. completion date: August 2007

Study information

• Verified date: February 2008
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older
• Eligibility: All patients hospitalized at BWH who have a PF4-Positive antibody test

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heparin-Induced Thrombocytopenia
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Baroletti SA, Goldhaber SZ. Heparin-induced thrombocytopenia. Circulation. 2006 Aug 22;114(8):e355-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of HIT associated with UFH and LMWH		30 Days	No
Primary	Outcomes of patients with HIT		30 Days	No
Primary	Adverse events associated with alternative anticoagulants used to treat HIT		30 Days	No
Secondary	Mortality		30 Days	No
Secondary	Hemorrhagic Events		30 Days	No
Secondary	Thrombotic Events		30 Days	No

External Links

•   North American Thrombosis Forum