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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Ministry of Health, Labour and Welfare, Japan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:
NCT00198575
First received: September 12, 2005
Last updated: February 15, 2006
Last verified: February 2006
  Purpose

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.


Condition
Heparin-Induced Thrombocytopenia

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Labour and Welfare, Japan:

Estimated Enrollment: 1500
Study Start Date: November 2004
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198575

Locations
Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan
Nagoya University Hospital
Nagoya, Aichi, Japan
Nagoya Daini Red Cross Hospital
Nagoya, Aichi, Japan
National Hospital Organization Hakodate National Hospital
Hakodate, Hokkaido, Japan
Kurume University Hospital
Kurume, Hukuoka, Japan
Kobe University Hospital
Kobe, Hyogo, Japan
Kobe City General Hospital
Kobe, Hyogo, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
National Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Sakakibara Memorial Hospital
Fuchu, Tokyo, Japan
National Hospital Organization Iwakuni Clinical Center
Iwakuni, Yamaguchi, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Shigeki Miyata, MD, PhD National Cerebral and Cardiovascular Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00198575     History of Changes
Other Study ID Numbers: 15C-1-3
Study First Received: September 12, 2005
Last Updated: February 15, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ministry of Health, Labour and Welfare, Japan:
heparin-induced thrombocytopenia
cardiovascular surgery
percutaneous coronary intervention

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014