Novel Therapies in Hemostasis and Transfusion

止血和输血的新疗法

• 批准号: 7681051
• 负责人: JAMES BRUCE BUSSEL
• 金额: $ 21万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7681051
• 关键词: Clinical; Clinical Trials; Conduct Clinical Trials; Data; Diagnosis; Disease; Eligibility Determination; Ensure; Goals; Growth Factor; Health Personnel; Hemostatic Agents; Hemostatic function; Hospitals; Individual; Informed Consent; Investigational Drugs; Knowledge; Laboratories; Medical center; Medicine; New England; New York; Participant; Patients; Presbyterian Church; Protocols documentation; Recruitment Activity; Research; Research Ethics Committees; Research Institute; Research Personnel; Resources; Safety Management; Site; Specimen; Therapy Clinical Trials; Training; Transfusion; blood product; cytokine; human subject; novel

DESCRIPTION (provided by applicant) TMH CTN is a national resource for the advancement of knowledge and understanding in the fields of transfusion medicine and hemostasis. The network will promote the efficient comparison of new management strategies for individuals with hemostatic disorders and evaluate new and existing blood products and cytokines for treatment of hematologic disorders. Weill Cornell Medical Center/New York Presbyterian Hospital is one of the 17 Core sites in this network. Cornell hopes to help accelerate research of blood products and novel growth factors in the treatment of hemostatic disorders, standardize approaches to existing diagnoses and treatments, evaluate new treatments, emphasize clinical trials to facilitate optimal therapy, and conduct therapeutic trials researching investigational drugs or blood products. In order to accomplish these goals, we are going to conduct clinical trials that are/will be approved to use human subjects by our IRB, the Data Safety and Management Board, the New England Research Institute Steering Committee, and the executive committee. As a core clinical centers in the TMH network, we are responsible for recruiting, examining, and treating study participants; and for collecting all clinical, laboratory, demographic, and other data required by each TMH Network study. We recruit patients by determining their eligibility for a study and obtaining their informed consent. All examinations of patients, treatment of patients, and attainment of patient specimens are conducted by trained medical personnel. Dr. James Bussel, as our site's Primary Investigator, is responsible for ensuring that all aspects of TMH Network protocols are followed.

描述（由申请人提供） TMH CTN 是促进输血医学和止血领域知识和理解的国家资源。该网络将促进止血疾病患者新管理策略的有效比较，并评估用于治疗血液疾病的新的和现有的血液制品和细胞因子。威尔康奈尔医疗中心/纽约长老会医院是该网络中的 17 个核心站点之一。康奈尔大学希望帮助加速​​血液制品和新型生长因子在止血疾病治疗中的研究，标准化现有诊断和治疗方法，评估新疗法，强调临床试验以促进最佳治疗，并开展研究药物或血液制品的治疗试验。为了实现这些目标，我们将进行临床试验，这些试验已/将被我们的 IRB、数据安全和管理委员会、新英格兰研究所指导委员会和执行委员会批准使用人类受试者。作为TMH网络中的核心临床中心，我们负责招募、检查和治疗研究参与者；用于收集每项 TMH 网络研究所需的所有临床、实验室、人口统计和其他数据。我们通过确定患者参与研究的资格并获得他们的知情同意来招募患者。所有对患者的检查、患者的治疗以及患者标本的获取均由经过培训的医务人员进行。 James Bussel 博士作为我们网站的主要研究员，负责确保 TMH 网络协议的所有方面都得到遵守。