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

Carelon Research

Status: Completed

Conditions: Heparin Induced Thrombocytopenia

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01178333

U01HL072268 (U.S. NIH Grant/Contract)

678

Details and patient eligibility

About

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.

Full 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.

Enrollment: 668 patients

Sex: All

Volunteers: No Healthy Volunteers

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