Transfusion Medicine/Hemostasis Clinical Research Netwo*

描述（由申请人提供）： 血液学和止血疾病是住院、发病和死亡的常见原因。 然而，这些疾病，单独考虑，是不常见的，这使得他们很难研究的背景下，罕见疾病的治疗是不标准的医疗保健系统和单一机构的研究不能积累足够数量的患者，以达到有意义的结论。 出于这个原因，需要一个中心网络来合作研究这些疾病。 在本申请中，我们将追求两个主要目标。 首先，我们将概述凯斯西储大学医学院（CWRU）/克利夫兰大学医院（UHC）在止血和输血医学方面的临床研究活动，并证明将CWRU/UHC纳入止血/输血医学临床研究联盟的益处。 我们机构在这方面的优势包括：1）在这里接受治疗的先天性和获得性血液病成人和儿童患者数量庞大，2）CWRU/UHC癌症中心，一个NCI指定的综合性癌症中心，通过该中心，一个完善的临床研究基础设施可用于管理和监测我们的研究活动，和3）我们的教师在积累患者的NIH赞助的临床试验的经验和跟踪记录。 我们的第二个目标是为研究两种常见的血小板减少性疾病，肝素相关性血小板减少症（HIT）和免疫性血小板减少性紫癜（ITP）提供一个全面的理论基础和实验方法。 关于HIT，我们将评估新诊断的HIT和“无症状性血小板减少症”患者亚临床血栓形成的发生率，并评估这些患者是否需要替代抗凝治疗。 我们假设这种治疗可能不是在所有情况下都有必要。 我们还将直接比较refluxdan和argotraban在预防该患者组血栓形成方面的疗效。 在我们的第二个项目中，我们将评估H。pylori感染，并确定是否根除H. pylori诱导ITP缓解。 我们假设许多ITP患者会对这种干预措施产生反应。 这些研究的成功完成将为这些疾病的管理提供重要的见解，这些疾病将对其管理产生重要和直接的影响。

DESCRIPTION (provided by applicant): Hematologic and hemostatic disorders are common causes of hospital admissions, morbidity and mortality. However, these disorders, considered individually, are uncommon, a fact that has made them difficult to study in the context of a health care system in which therapy of rare disorders is not standardized and single institution studies cannot accrue sufficient numbers of patients to reach meaningful conclusions. For this reason, a network of centers to collaboratively study such disorders is needed. In this application, we will pursue two primary goals. First, we will provide an overview of clinical research activity in hemostasis and transfusion medicine at Case Western Reserve University School of Medicine (CWRU)/University Hospitals of Cleveland (UHC), and demonstrate the benefits of including CWRU/UHC in the hemostasis/transfusion medicine clinical research consortium. The strengths of our institution in this regard include 1) the large volume of adult and pediatric patients with congenital and acquired hematologic disorders who receive care here, 2) the CWRU/UHC Cancer Center, an NCI-designated comprehensive cancer center through which a well established clinical research infrastructure is available for administering and monitoring our research activities, and 3) the experience and track record of our faculty in accruing patients to NIH-sponsored clinical trials. Our second goal will be to provide a comprehensive rationale and experimental approach for studying two common thrombocytopenic disorders, heparin-associated thrombocytopenia (HIT) and immune thrombocytopenic purpura (ITP). With regard to HIT, we will assess the incidence of subclinical thrombosis in newly diagnosed patients with HIT and "asymptomatic thrombocytopenia", and evaluate the need for alternative anticoagulation in these patients. We hypothesize that such therapy may not be necessary in all cases. We will also directly compare the efficacy of refludan and argotraban in preventing the development of thrombi in this patient group. In our second project, we will assess the incidence of H. pylori infection in a large cohort of patients with ITP, and determine whether eradication of H. pylori induces a remission of ITP. We hypothesize that many patients with ITP will respond to this intervention. Successful completion of these studies will provide important insights into the management of each of these disorders that will have an important and immediate impact on their management.