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A Study on the Prevalence of Heparin-Induced Thrombocytopenia in Cardiovascular Patients

NCT00198575 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2006-02-16

No results posted yet for this study

Summary

Several clinical studies in Western countries have revealed that the prevalence of HIT is 0.5 to 5%, varying depending on the clinical setting. Thirty to 50% of HIT patients suffer from thromboembolic events, and the mortality of HIT is 10 to 20%. In contrast, many physicians in Japan report no experience in treating HIT, although approximately 200,000 patients per year receive heparin. This raises the possibility that the prevalence of HIT might be much lower in Japan than in Western countries. In fact, neither the drug for HIT treatment nor the laboratory test for HIT diagnosis has been approved by the Pharmaceutical Affairs Law in Japan. We have therefore conducted a multi-center, prospective cohort study to determine the prevalence and profile of HIT in patients undergoing cardiovascular surgery or percutaneous coronary intervention. Approximately 1,500 patients will be enrolled in this study.

Conditions

  • Heparin-Induced Thrombocytopenia

Sponsors & Collaborators

  • Ministry of Health, Labour and Welfare, Japan

    lead OTHER_GOV

Principal Investigators

  • Shigeki Miyata, MD, PhD · National Cerebral and Cardiovascular Center, Japan

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Completion
2006-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00198575 on ClinicalTrials.gov