A Study on the Prevalence of Heparin-Induced Thrombocytopenia in Cardiovascular Patients
A Multicenter, Prospective Cohort Study to Determine the Prevalence and Profile of Heparin-Induced Thrombocytopenia in Patients Undergoing Cardiovascular Surgery or Percutaneous Coronary Intervention
1 other identifier
observational
1,500
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2004
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFebruary 16, 2006
February 1, 2006
September 12, 2005
February 15, 2006
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Adult males or females who meet the criteria listed below:
- Patients who are \>=20 years of age
- Patients scheduled to undergo cardiovascular surgery or patients with acute coronary syndrome scheduled to undergo percutaneous coronary intervention
- Patients willing and able to give informed consent
You may not qualify if:
- Patients who have a documented history of heparin-induced thrombocytopenia
- Chronic thrombocytopenia (\<100,000/μL)
- Hematopoietic malignancy
- Patients who receive an anticancer drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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, 565-8565, Japan
Sakakibara Memorial Hospital
Fuchū, Tokyo, Japan
National Hospital Organization Iwakuni Clinical Center
Iwakuni, Yamaguchi, Japan
Study Officials
- STUDY CHAIR
Shigeki Miyata, MD, PhD
National Cerebral and Cardiovascular Center, Japan
Study Design
- Study Type
- observational
- Observational Model
- DEFINED POPULATION
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
November 1, 2004
Study Completion
March 1, 2006
Last Updated
February 16, 2006
Record last verified: 2006-02