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.
Observational
Observational Model: Case-Only, Time Perspective: Retrospective
Time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis
From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.
No
Susan F Assmann, PhD
Principal Investigator
New England Research Institutes
United States: Federal Government
678
NCT01178333
June 2010
December 2010
Name | Location |
---|---|
University of Iowa | Iowa City, Iowa 52242 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Minnesota | Minneapolis, Minnesota 55455 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Duke University Medical Center | Durham, North Carolina 27710 |
Cleveland Clinic | Cleveland, Ohio 44195 |
Johns Hopkins | Baltimore, Maryland 21231 |
Cornell University | New York, New York 10021 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
University of North Carolina, Chapel Hill | Chapel Hill, North Carolina 27599 |
Children's Hospital, Boston | Boston, Massachusetts 02115 |
Gunderson Clinic | LaCrosse, Wisconsin 54601 |
Tulane University | New Orleans, Louisiana 70112-2699 |
Case Western Reserve University School of Medicine | Cleveland, Ohio 44106-7284 |
Froedtert | Milwaukee, Wisconsin 53201 |