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

NCT ID: NCT00198575

Last Updated: 2006-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2006-03-31

Brief 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.

Detailed 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.

Conditions

Heparin-Induced Thrombocytopenia

Study Design

• Observational Model Type: DEFINED_POPULATION
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Shigeki Miyata, MD, PhD

Role: STUDY_CHAIR

National Cerebral and Cardiovascular Center, Japan

Locations

Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

National Hospital Organization Hakodate National Hospital

Hakodate, Hokkaido, Japan

Kurume University Hospital

Kurume, Hukuoka, Japan

Kobe City General Hospital

Kobe, Hyōgo, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Iwate Medical University Hospital

Morioka, Iwate, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Kumamoto, Japan

National Cardiovascular Center

Suita, Osaka, Japan

Sakakibara Memorial Hospital

Fuchū, Tokyo, Japan

National Hospital Organization Iwakuni Clinical Center

Iwakuni, Yamaguchi, Japan

Countries

Japan

Other Identifiers

15C-1-3

Identifier Type: -

Identifier Source: org_study_id