Evaluating the Presence of Blood Clots in People With Heparin-Induced Thrombocytopenia (HIT) (The HOT Study)

Stopped early

Conditions studied: Thrombocytopenia

In brief

Heparin-induced thrombocytopenia (HIT), a condition characterized by low platelet levels and possible blood clots, occurs in a small number of people after treatment with the drug heparin. Some people with HIT may show symptoms of a blood clot at the time of HIT diagnosis, but in another form of HIT, known as isolated HIT, people do not show blood clot symptoms even though they might have a blood clot. This study will use ultrasound tests to evaluate the presence of blood clots at the time of an HIT diagnosis and in the following month.

Key facts

Study ID

NCT00594685

Run by

Carelon Research

People needed

10

Starts

2008-01-01

Expected to finish

2008-09-01

Last updated by the study team

2013-03-13

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In the 72 hours prior to study entry, participant has been diagnosed with "isolated HIT," as defined by an unexplained platelet count drop of over 50% that occurs after exposure to UFH (UnFractionated Heparin)/LMWH (Low Molecular Weight Heparin) at any time in the 4 to 14 days before the positive heparin-PF4 antibody test was sent(even if the person is no longer on UFH/LMWH)
• Currently hospitalized
• Available for study follow-up for at least 28 days after study entry
• No contraindications to ultrasound examination of upper and lower extremities
• For participants less than 7 years old, no contraindications to ultrasound examination of abdomen
• Participants are eligible whether or not they are receiving any therapy for isolated HIT

You may not qualify if…

• Documented new venous or arterial thrombosis while on heparin
• Pregnant
• Ongoing active bleeding (as determined by the site investigator)
• Currently using a extracorporeal membrane oxygenator, chronic veno-venous hemofiltration, left ventricular support device, intra-aortic balloon pump, or any other mechanical heart pump
• Coronary artery bypass surgery occured within 96 hours prior to the time when the positive HIT test was drawn

Where it is running

• Emory University — Atlanta, Georgia, United States
• University of Iowa — Iowa City, Iowa, United States
• Tulane University — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States
• Gunderson Lutheran Clinic — La Crosse, Wisconsin, United States
• University of Wisconsin, Madison — Madison, Wisconsin, United States
• St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• Froedtert Memorial Lutheran Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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