Retrovirus Epidemiology Donor Study-II (REDS-II)
調査の概要
状態
詳細な説明
BACKGROUND:
REDS-I was established to address important blood safety issues involving human retroviruses. On July 17, 1989 the NHLBI awarded contracts to five major blood centers and a coordinating center to develop a major multicenter epidemiologic study of the human retroviruses HIV-1, HIV-2, HTLV-I, and HTLV-II in volunteer U.S. blood donors. The original mission of REDS-I was to initiate and facilitate investigations of human retroviruses in volunteer blood donors from areas of the country at varying risk for HIV. During the course of the project, NHLBI expanded the original REDS-I mission to investigate critical questions posed by the blood banking and transfusion medicine communities that were essential to ensuring an adequate blood supply without compromising blood safety. The overall REDS-I program includes epidemiologic, laboratory, and clinical investigations, and provides a comprehensive framework for monitoring U.S. blood donations, and more recently transfusion recipients, for infectious disease markers. The operational and database structure of REDS-I, specifically designed to study U.S. blood safety and availability, has also provided a framework for rapid analytical response to other research questions of significant importance to the safety of the blood supply. Since its inception, investigators have made major contributions in assessing: the risk of contracting transfusion-transmitted infectious agents; HIV and HCV test screening; donor characteristics and behaviors; and ways of reducing HIV risk from transfusion. REDS-I investigators work closely with the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and Office of the Secretary, Department of Health and Human Services (DHHS) to provide data and analyses for important policy decisions. Liaisons with test manufacturers have enabled the rapid study of test procedures of critical importance to blood safety and availability.
DESIGN NARRATIVE:
The objectives of the Retrovirus Epidemiology Donor Study-II (REDS-II) are to conduct epidemiological, laboratory, and survey research on volunteer blood donors within the United States to ensure the safety and availability of the United States' blood supply. This includes monitoring known blood-borne infectious agents, rapidly evaluating the impact of emerging pathogens, assessing the safety implications of changes in laboratory and/or blood donor screening protocols and examining blood supply and availability issues. Addressing issues concerned with the safety and availability of the United States' blood supply will be the cornerstone of the National Heart, Lung, and Blood Institute's Retrovirus Epidemiology Donor Study. These issues include: a) the risks of transfusion-transmissible infections and their trends through time--these include infectious agents currently undergoing laboratory screening as well as new and emerging agents such as West Nile Virus (WNV) which is about to be screened for in the U.S. under experimental protocols; b) ways to reduce the risks of transfusion-transmissible infections; c) HIV, HTLV, HCV, and HBV test screening methodologies; d) donor characteristics, behaviors, and donation return patterns of U.S. blood donors; and e) the effectiveness and safety of various strategies implemented to increase the U.S. blood supply.
研究の種類
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
研究計画
研究はどのように設計されていますか?
協力者と研究者
捜査官
- Michael Busch、Blood Systems Research Institute
- Jerome Gottschall、Blood Center of Southeastern Wisconsin, Inc.
- Christopher Hillyer、Emory University
- Ram Kakaiya、Institute for Transfusion Medicine
- Edward Murphy、University of California, San Francisco
- Jorge Rios、American Red Cross Blood Services, New England Region
- Ronald Sacher、University of Cincinnati
- George Schreiber、Westat, Inc.
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1243
個々の参加者データ (IPD) の計画
試験データ・資料
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個人参加者データセット
情報識別子:REDS II-CORE情報コメント:NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
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手続きマニュアル
情報識別子:REDS II-CORE
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個人参加者データセット
情報識別子:REDS II-LAPS情報コメント:NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
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研究プロトコル
情報識別子:REDS II-LAPS
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研究フォーム
情報識別子:REDS II-LAPS
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手続きマニュアル
情報識別子:REDS II-LAPS
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個人参加者データセット
情報識別子:REDS II-MS情報コメント:NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
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研究プロトコル
情報識別子:REDS II-MS
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手続きマニュアル
情報識別子:REDS II-MS
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個人参加者データセット
情報識別子:REDS II-RISE情報コメント:NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
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研究プロトコル
情報識別子:REDS II-RISE
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研究フォーム
情報識別子:REDS II-RISE
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手続きマニュアル
情報識別子:REDS II-RISE
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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