Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study

NCT ID: NCT01178333

Last Updated: 2015-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 668 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-12-31

Brief Summary

HIT-RADIO is a study of patients who had a positive heparin PF-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals. The study will collect and analyse information that is already in the patients' medical records. Information about laboratory values (such as platelet counts), treatments (such as medications), and outcomes (such as blood clots, amputation, and death) will be included.

Detailed Description

HIT-RADIO is a retrospective chart-review study of patients who had a positive heparin PF-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals associated with the Transfusion Medicine/Hemostasis Clinical Trials Network .

Heparin-induced thrombocytopenia (HIT) is a major complication of the administration of heparin and can result in life-threatening thrombosis with or without thrombocytopenia (HIT-T) or can produce thrombocytopenia without clinically symptomatic thrombosis ("isolated" HIT). Isolated heparin-induced thrombocytopenia is defined as a fall in platelet count associated with a positive heparin PF-4 antibody test, in the absence of clinically overt thrombosis. While the treatment of HIT-T (HIT with thrombosis) with anticoagulation is well established, the risks and treatment of isolated HIT are unclear.

It is anticipated that this data analysis will provide a current overview of the implications of a positive heparin PF-4 antibody test in clinical practice. It should determine the percentage of positive heparin PF-4 antibody tests that are associated with thrombocytopenia and thrombosis (HIT-T) or "isolated" HIT at diagnosis and the subsequent major clinical outcomes of death, limb amputation/gangrene, and new thrombosis. No "snapshot" of such HIT patients has been conducted in the past decade and the results will be important in assessing the impact of HIT in current medical care as well as documenting current treatment strategies.

Conditions

Heparin Induced Thrombocytopenia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• All subjects with a positive heparin PF-4 antibody test occurring between 1/21/2008 and 9/25/2008
• Medical record available for the admission during which the positive heparin PF-4 antibody test was obtained

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Carelon Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan F Assmann, PhD

Role: PRINCIPAL_INVESTIGATOR

Carelon Research

David Kuter, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Eliot Williams, MD PHD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Kenneth Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Versiti

Ronald Go, MD

Role: PRINCIPAL_INVESTIGATOR

Gunderson Clinic

Keith McCrae, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Ellis Neufeld, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Lynne Uhl, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Judith Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

James Bussel, MD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Thomas Ortel, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Jodi Segal, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Barbara Konkle, MD

Role: PRINCIPAL_INVESTIGATOR

Bloodworks

Cindy Leissinger, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Thomas Raife, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Ann Zimrin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Greenebaum Cancer Center

Jeffrey McCullough, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Nigel Key, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Bruce Sachais, MD PHD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Joseph Kiss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Institute for Transfusion Medicine

Locations

University of Iowa

Iowa City, Iowa, United States

Tulane University

New Orleans, Louisiana, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Children's Hospital, Boston

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Cornell University

New York, New York, United States

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Case Western Reserve University School of Medicine

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Gunderson Clinic

La Crosse, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Froedtert

Milwaukee, Wisconsin, United States

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

U01HL072268

Identifier Type: NIH

Identifier Source: secondary_id

View Link

678

Identifier Type: -

Identifier Source: org_study_id