Marian Anderson Sickle Cell Center-Sickle Cell Disease Clinical Research Network

玛丽安·安德森镰状细胞中心-镰状细胞病临床研究网络

• 批准号: 7236624
• 负责人: Carlton Dampier
• 金额: $ 15.55万
• 依托单位: DREXEL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7236624
• 关键词: Address; Adolescent; Adult; Age; Amitriptyline; Arts; Basic Science; Caring; Certification; Child; Child Advocacy; Childhood; Class; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communities; Companions; Credentialing; Data; Data Coordinating Center; Delaware; Development; Dose; Double-Blind Method; Drug Kinetics; Effectiveness; Enrollment; Funding; Goals; Head; Headache; Hospitals; Infant; Institutes; Kentucky; Lead; Medical; Migraine; Morphine; Numbers; Outcome; Outcome Measure; Pain; Patient Care; Patients; Pediatric Hospitals; Performance; Pharmacodynamics; Pharmacogenetics; Phase; Philadelphia; Placebo Control; Psychosocial Factor; Recurrence; Research; Research Activity; Research Infrastructure; Research Personnel; Role; Sickle Cell; Sickle Cell Anemia; Site; Standards of Weights and Measures; Supervision; Therapeutic; Therapy Clinical Trials; Time; Training; Treatment Protocols; Universities; University Hospitals; Valproic Acid; Variant; abstracting; day; follow-up; innovation; insight; placebo controlled study; programs; prophylactic; research study; sickling

DESCRIPTION (provided by applicant): This Clinical Center will provide support for state-of-the-art clinical research activities for 962 SCD patients at St. Christopher's Hospital for Children (SCHC), Thomas Jefferson University Hospital (TJUH), Kosair Children's Hospital (KCH), and duPont Children's Hospital (DCH). Three of these sites (SCHC, KCH, TJUH) are currently part of the Marian Anderson Comprehensive (MAC) Sickle Cell Center and currently lead enrollment in several of the phase l/ll/lll Inter-Center studies sponsored by the Comprehensive Centers, also under the direction of Dr. Dampier and Ms. Rockstein through the MAC Center's Clinical Core. The Center PI and Center Chief Clinical coordinator at St. Christopher's Hospital are both credentialed by the Association of Clinical Research Professionals (Clinical Trial Investigator, and CRA certifications respectively) and have a several year record of successful coordination and supervision of research activities at the various Center sites. The proposed network clinical trials address important issues in clinical care of SCD patients. The first study is a phase IV of headache management that will build on descriptive and epidemiologic data being gathered as part of the C-data project of the Comprehensive Center's Network. This study proposes a 4 month placebo controlled RCT of prophylactic therapy (amitryptline with or without CBT training) in children aged 7- 17 years with >/= 2 headaches per month in the preceding 3 months, while a companion study will evaluate the effectiveness of amitriptyline or divalproex ER in reducing the number of days of recurrent headaches in a 4 month double blind, parallel treatment, placebo-controlled trial of adults with >/= 2 migraine headaches per month. The second clinical trial will examine the efficacy of two alternative morphine PCA dosing regimens in comparison to a standard PCA therapy. It will also determine whether variations in morphine pharmacokinetics, in morphine pharmacodynamics as determined by pharmacogenetics, or subject psychosocial factors, alter the efficacy of the various PCA regimens. An Outcomes Core is also proposed which will focus on developing a variety of outcome measures and descriptive clinical information to support the appropriate, conduct of high quality clinical trials of therapies for sickle cell-related pain. The performance of these studies will advance the clinical understanding of sickle cell-related pain and its consequences. Their results will stimulate the development of innovative clinical trials of sickle pain. (End of abstract)

描述（由申请人提供）： 这个临床中心将为圣克里斯托弗儿童医院（SCHC），托马斯·杰斐逊大学医院（TJUH），Kosair儿童医院（KCH）和杜邦儿童医院（DCH）的962例SCD患者提供支持的最先进临床研究活动。这些地点中的三个（SCHC，KCH，TJUH）目前是Marian Anderson综合（MAC）镰状细胞中心的一部分，目前在综合中心发起的几个阶段L/LL/LLL Inter-Center研究中，也是在Dampier博士和Rockstein女士通过Mac Centrical Core的指导下。圣克里斯托弗医院的中心PI和中心首席临床协调员均由临床研究专业人员协会（分别为临床试验研究者和CRA认证）认证，并且在各个中心地点都有成功协调和监督研究活动的记录。拟议的网络临床试验解决了SCD患者临床护理中的重要问题。第一项研究是头痛管理的IV阶段，该研究将基于综合中心网络C-DATA项目的一部分，基于被收集的描述性和流行病学数据。这项研究提出了4个月的安慰剂控制的预防治疗RCT（有或不接受CBT培训的Amitryptline（Amitryptline），年龄在7-17岁之间，在前3个月中>/= 2个头痛，而同伴研究将评估Amitriptyline或Divalproex ER的有效性，并降低了Recrirn node of Armitriptyline或Divalproex ER的有效性。 >/= 2个偏头痛的成年人的安慰剂对照试验。与标准PCA治疗相比，第二项临床试验将检查两种替代吗啡PCA剂量方案的功效。它还将确定吗啡药代动力学的变化，在药物遗传学或受试者社会心理因素确定的吗啡药效学中是否会改变各种PCA方案的功效。还提出了一个结果核心，该核心将着重于制定各种结果指标和描述性临床信息，以支持适当的，高质量的临床试验，以实现镰状细胞相关疼痛的疗法。 这些研究的表现将提高对镰状细胞相关疼痛及其后果的临床理解。他们的结果将刺激镰状疼痛的创新临床试验的发展。 （抽象的结尾）