Viewing Study NCT00198575



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Last Modification Date: 2024-10-26 @ 9:17 AM
Study NCT ID: NCT00198575
Status: UNKNOWN
Last Update Posted: 2006-02-16
First Post: 2005-09-12

Brief Title: A Study on the Prevalence of Heparin-Induced Thrombocytopenia in Cardiovascular Patients
Sponsor: Ministry of Health Labour and Welfare Japan
Organization: Ministry of Health Labour and Welfare Japan

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2006-02
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Several clinical studies in Western countries have revealed that the prevalence of HIT is 05 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 200000 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 1500 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 100000μL 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 05 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 200000 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 1500 patients will be enrolled in this study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None