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心血管疾患患者におけるヘパリン誘発性血小板減少症の有病率に関する研究

基本情報

NCT ID
NCT00198575
ステータス
不明
試験のフェーズ
-
試験タイプ
観察
目標被験者数
1,500
治験依頼者名
Ministry of Health, Labour and Welfare, Japan

概要

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.

対象疾患

Heparin-Induced Thrombocytopenia

依頼者(Sponsor)

実施施設 (17)

名古屋大学医学部附属病院

Nagoya, Aichi-ken, Japan

独立行政法人 国立病院機構 岩国医療センター

Iwakuni, Yamaguchi, Japan

国立研究開発法人 国立循環器病研究センター

Suita, Osaka, Japan

Sakakibara Memorial Hospital

Fuchū, Tokyo, Japan

東海大学医学部付属病院

Isehara, Kanagawa, Japan

久留米大学病院

Kurume, Hukuoka, Japan

National Hospital Organization Hakodate National Hospital

Hakodate, Hokkaido, Japan

日本赤十字社愛知医療センター名古屋第二病院

Nagoya, Aichi-ken, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

神戸市立医療センター中央市民病院

Kobe, Hyōgo, Japan

国立病院機構熊本医療センター

Kumamoto, Kumamoto, Japan

Kobe City General Hospital

Kobe, Hyōgo, Japan

神戸大学医学部附属病院

Kobe, Hyōgo, Japan

National Hospital Organization Hakodate National Hospital

Hakodate, Hokkaido, Japan

岩手医科大学附属病院

Morioka, Iwate, Japan

Sakakibara Memorial Hospital

Fuchū, Tokyo, Japan

独立行政法人国立病院機構 名古屋医療センター

Nagoya, Aichi-ken, Japan