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

Descriptive Information
Brief Title † Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study
Official Title † Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study (HIT-RADIO Study)
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.
Study Phase N/A
Study Type † Observational
Study Design † Observational Model: Case-Only, Time Perspective: Retrospective
Primary Outcome Measure † Time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis
Secondary Outcome Measure † Time to occurrence of radiographically confirmed thromboembolism
Condition † Heparin Induced Thrombocytopenia
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 673
Start Date † June 2010
Completion Date December 2010
Primary Completion Date December 2010
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
Gender Both
Ages N/A - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01178333
Organization ID 678
Secondary IDs †† U01HL072268
Responsible Party Sponsor
Study Sponsor † New England Research Institutes
Collaborators †† National Heart, Lung, and Blood Institute (NHLBI)
Investigators † Principal Investigator: Susan F Assmann, PhD, New England Research Institutes
Information Provided By
Verification Date March 2013
First Received Date † August 6, 2010
Last Updated Date March 11, 2013
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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