Clinical trial NCT01178333: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heparin Induced Thrombocytopenia
Keywords: Thrombocytopenia
Heparin
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-08-10
Enrollment: 668
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with a positive heparin PF-4 antibody test drawn between 1/21/2008 and 9/25/2008

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.

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

Primary outcomes:
measure: Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis
timeFrame: From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.
measure: Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis
timeFrame: From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.
Secondary outcomes:
measure: Time to Death
timeFrame: From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Time to Death
timeFrame: From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Time to Occurrence of Limb Amputation or Limb Gangrene
timeFrame: From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Time to Occurrence of Radiographically Confirmed Thromboembolism
timeFrame: From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Time to Occurrence of Major Bleeding
timeFrame: From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Time to Occurrence of Major Bleeding
timeFrame: From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Proportion of Subjects With HIT With Thrombosis (HIT-T) and Isolated HIT
timeFrame: From the date 5 days before the positive heparin PF-4 antibody test was drawn to the date it was drawn
measure: Type of Heparin Exposure - Unfractionated Heparin (UFH)
timeFrame: Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn
measure: Type of Heparin Exposure - Low Molecular Weight Heparin (LMWH)
timeFrame: Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn
measure: Relationship of the Heparin PF-4 (Platelet Factor 4) Antibody Titer to the Clinical Diagnosis
timeFrame: From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Relationship of the Heparin PF-4 Antibody Titer to the Degree of Thrombocytopenia
timeFrame: From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Relationship of the Heparin PF-4 Antibody Titer to the Primary Endpoint
timeFrame: From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Use of Treatment (Non-heparin Anticoagulant) Used in Hospital
timeFrame: From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Use of Treatment (Non-heparin Anticoagulant) Used at the Time of Discharge
timeFrame: From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first
measure: Time to Platelet Recovery, Among Subjects With a Low Platelet Count When the Positive PF4 Antibody Test Was Drawn
timeFrame: From the time that the nadir platelet count was drawn until hospital discharge, death, or day 45, whichever occurred first
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital, Boston
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Cornell University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University School of Medicine
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: LaCrosse
country: United States
facility: Gunderson Clinic
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Carelon Research
name: Susan F Assmann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: David Kuter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Eliot Williams, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Versiti
name: Kenneth Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gunderson Clinic
name: Ronald Go, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Keith McCrae, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Ellis Neufeld, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Lynne Uhl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Judith Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: James Bussel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Thomas Ortel, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Jodi Segal, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Bloodworks
name: Barbara Konkle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University
name: Cindy Leissinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Thomas Raife, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland Greenebaum Cancer Center
name: Ann Zimrin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Jeffrey McCullough, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Nigel Key, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Bruce Sachais, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Institute for Transfusion Medicine
name: Joseph Kiss, MD
role: PRINCIPAL_INVESTIGATOR
References: