Overview

This trial is active, not recruiting.

Condition heparin-induced thrombocytopenia
Sponsor Ministry of Health, Labour and Welfare, Japan
Start date November 2004
End date March 2006
Trial size 1500 participants
Trial identifier NCT00198575, 15C-1-3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model defined population
Primary purpose screening
Time perspective longitudinal

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Adult males or females who meet the criteria listed below: 1. Patients who are >=20 years of age 2. Patients scheduled to undergo cardiovascular surgery or patients with acute coronary syndrome scheduled to undergo percutaneous coronary intervention 3. Patients willing and able to give informed consent Exclusion Criteria: 1. Patients who have a documented history of heparin-induced thrombocytopenia 2. Chronic thrombocytopenia (<100,000/μL) 3. Hematopoietic malignancy 4. Patients who receive an anticancer drug

Additional Information

Official title A Multicenter, Prospective Cohort Study to Determine the Prevalence and Profile of Heparin-Induced Thrombocytopenia in Patients Undergoing Cardiovascular Surgery or Percutaneous Coronary Intervention
Description Heparin is an important anticoagulation treatment, especially for cardiovascular patients. Recently, heparin-induced thrombocytopenia type II (HIT) has been shown to be an immune-mediated, life-threatening side effect of heparin therapy. Antibodies against heparin-platelet factor 4 (HIT antibodies), induced by heparin administration, are the major cause of HIT. HIT antibodies can stimulate platelets and endothelial cells, resulting in an excess production of thrombin, inducing thrombocytopenia and thromboembolic events. HIT typically occurs 5 to 14 days after the initial administration of heparin (typical-onset). HIT antibodies are transient but can be detected for about 100 days after the cessation of heparin treatment. Thus, some patients develop HIT either days after discontinuing heparin (delayed-onset) or soon after the re-administration of heparin (rapid-onset). HIT is clinically diagnosed by a drop in platelet count to less than 100,000/μL or a 50% decrease in platelets after the initiation of heparin therapy with no apparent explanation other than HIT. A positive laboratory test for HIT antibodies supports the clinical diagnosis. 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2006.
Information provided to ClinicalTrials.gov by Ministry of Health, Labour and Welfare, Japan.