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Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study (HIT-RADIO Study)

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Heparin Induced Thrombocytopenia

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Trial Information

Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study (HIT-RADIO Study)

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.

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

Time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis

Outcome Time Frame:

From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.

Safety Issue:


Principal Investigator

Susan F Assmann, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New England Research Institutes


United States: Federal Government

Study ID:




Start Date:

June 2010

Completion Date:

December 2010

Related Keywords:

  • Heparin Induced Thrombocytopenia
  • Thrombocytopenia
  • Heparin
  • Thrombocytopenia



University of IowaIowa City, Iowa  52242
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of MinnesotaMinneapolis, Minnesota  55455
University of PittsburghPittsburgh, Pennsylvania  15261
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Duke University Medical CenterDurham, North Carolina  27710
Cleveland ClinicCleveland, Ohio  44195
Johns HopkinsBaltimore, Maryland  21231
Cornell UniversityNew York, New York  10021
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
University of North Carolina, Chapel HillChapel Hill, North Carolina  27599
Children's Hospital, BostonBoston, Massachusetts  02115
Gunderson ClinicLaCrosse, Wisconsin  54601
Tulane UniversityNew Orleans, Louisiana  70112-2699
Case Western Reserve University School of MedicineCleveland, Ohio  44106-7284
FroedtertMilwaukee, Wisconsin  53201