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

Heparin-Induced Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00198575
• Other study ID #: 15C-1-3
• Status: Active, not recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: February 15, 2006
• Start date: November 2004
• Est. completion date: March 2006

Study information

• Verified date: February 2006
• Source: Ministry of Health, Labour and Welfare, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Heparin-Induced Thrombocytopenia
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
Japan	Sakakibara Memorial Hospital	Fuchu	Tokyo
Japan	National Hospital Organization Hakodate National Hospital	Hakodate	Hokkaido
Japan	Tokai University Hospital	Isehara	Kanagawa
Japan	National Hospital Organization Iwakuni Clinical Center	Iwakuni	Yamaguchi
Japan	Kobe City General Hospital	Kobe	Hyogo
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	Kurume University Hospital	Kurume	Hukuoka
Japan	Iwate Medical University Hospital	Morioka	Iwate
Japan	Nagoya Daini Red Cross Hospital	Nagoya	Aichi
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Japan	National Cardiovascular Center	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan,