Development of a National Incompatible Kidney Transplant Registry
国家不相容肾移植登记处的发展
基本信息
- 批准号:7828833
- 负责人:
- 金额:$ 49.96万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2009
- 资助国家:美国
- 起止时间:2009-09-30 至 2011-07-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAdoptedAntibodiesAreaBiopsyBlood typing procedureClassificationClinicalClinical ManagementClinical TrialsComputer softwareComputing MethodologiesCountryDataDeath RateDevelopmentDialysis procedureFundingFutureGoalsGrowthHealthcare SystemsHistocompatibility TestingHuman ResourcesImmunogeneticsInstitutionInterviewKidneyKidney FailureKidney TransplantationLifeLife ExpectancyLinkLiving DonorsMentorsMentorshipMethodologyModalityOnline SystemsOutcomePathologyPatientsProceduresProtocols documentationProviderQuality of lifeRadiology SpecialtyRecordsRecruitment ActivityRegistriesRelianceResearchResearch InfrastructureResourcesStructureTechniquesTestingTimeTransplantationUnited StatesWaiting Listsbasecostdata structuredesensitizationdesignexperienceimprovedmathematical modelmeetingsmembernew technologypatient orientedprogramsprospectivetransplant registry
项目摘要
DESCRIPTION (provided by applicant):
Summary This application addresses broad Challenge Area (07) Enhancing Clinical Trials and specific Challenge Topic, 07-DK-103: Support for Registries. Live donor kidney transplantation is the best treatment for kidney failure, doubling life expectancy and significantly improving quality of life. However, it is estimated that 2000-4000 patients every year find a healthy, willing live donor but are relegated to forego the benefits of live donor renal transplantation because they are ABO or HLA incompatible with their donor. Some of these patients might find compatible matches through kidney paired donation, but those with broad HLA sensitization or hard-to-match blood types (over 50% of incompatible pairs) will not find matches through paired donation. Without incompatible kidney transplantation (IKT), the only other option for these patients is to join the 80,000-patient deceased donor waiting list, where waiting times average 5-7 years and death rates on dialysis exceed 10% per year. IKT is an emerging practice in which patients can receive kidney transplants across antibody barriers through the use of various desensitization techniques. Approximately 200 of these transplants are performed annually in the United States, of which approximately one-third are performed by a handful of high-volume centers and two-thirds are scattered across approximately 90 other very low-volume centers. However, two major challenges currently limit future growth in the field of IKT. First, there is a great need to study and validate specific components of the current protocols and develop best practice. This can only be accomplished if sufficient, detailed data from multiple centers can be collected in a prospective fashion; to date, only single-center studies have been available for analysis. Second, because IKT can be hard to implement due to its reliance on new technology in immunogenetics and pathology, there is a great need for mentoring of new provider teams by more experienced centers. This is currently limited by the inability to readily share detailed, integrated, longitudinal clinical, histological, radiographic, and immuogenetics data. In an effort to better understand IKT and mentor new centers building these programs, we propose to develop a National Incompatible Kidney Transplant Registry. We will design this registry based on a systematic set of in-depth interviews with personnel currently involved in this procedure, and then extend currently existing relational patient management software to accommodate the needs of this registry. We will then pilot test the registry on retrospective cases at our center, prospective cases at our center, and prospective cases from a handful of centers around the country. Finally, we will develop a long-term plan for sustainability. For sensitized patients, IKT is often the only viable treatment option, providing a significant (more than 3- fold) survival benefit to these patients when compared to the next-best available option, namely waiting on the deceased donor waiting list for a compatible donor. Expanding this treatment modality will not only save lives, decrease the long waiting list, and save the US healthcare system significant costs, but will also stimulate the expansion of transplant centers, tissue typing labs, and pathology labs nationwide. Although live donor kidney transplantation is the best treatment for kidney failure, thousands of patients each year have a healthy, willing donor but are relegated to forego the benefits of live donor transplantation because they are incompatible with their donor. Incompatible kidney transplantation is an emerging practice in which patients can receive kidney transplants from their incompatible donors, but this field has thus far been limited to single-center experiences where protocols cannot be validated, best practice cannot be developed, and mentorship of new centers by more experienced centers cannot be accomplished. The goal of this project is to create a detailed, integrated, National Incompatible Kidney Transplant Registry that will link clinical, biopsy, radiology, and antibody data from multiple centers throughout the United States in a way that will greatly improve and expand incompatible kidney transplantation.
描述(由申请人提供):
摘要本申请解决了广泛的挑战领域(07)增强临床试验和特定的挑战主题,07-DK-103:注册支持。活体供肾移植是肾衰竭的最佳治疗方法,可使预期寿命延长一倍,并显著改善生活质量。然而,据估计,每年有2000-4000名患者找到了健康的、愿意的活体供体,但由于他们与其供体ABO或HLA不相容而被降级以放弃活体供体肾移植的益处。这些患者中的一些可能通过肾脏配对捐赠找到匹配,但那些具有广泛HLA致敏性或难以匹配血型(超过50%的不相容对)的患者将无法通过配对捐赠找到匹配。如果没有不相容的肾移植(IKT),这些患者唯一的其他选择是加入80,000名患者的死亡供体等待名单,等待时间平均为5-7年,透析死亡率超过每年10%。IKT是一种新兴的实践,患者可以通过使用各种脱敏技术跨越抗体屏障接受肾移植。在美国,每年大约有200例移植手术,其中大约三分之一是由少数几个高容量中心进行的,三分之二分散在大约90个其他非常低容量的中心。然而,目前有两个主要挑战限制了IKT领域的未来增长。首先,非常需要研究和验证现行协议的具体组成部分,并制定最佳做法。只有在以前瞻性方式从多个中心收集到足够详细的数据时才能做到这一点;迄今为止,只有单中心研究可用于分析。其次,由于IKT依赖于免疫遗传学和病理学的新技术,因此很难实施,因此非常需要由更有经验的中心指导新的提供者团队。目前,这是有限的,无法容易地共享详细的,综合的,纵向的临床,组织学,放射学和免疫遗传学数据。为了更好地了解IKT和指导新的中心建立这些项目,我们建议建立一个国家不相容肾移植登记处。我们将设计这个注册表的基础上,一套系统的深入访谈人员目前参与这一进程,然后扩展现有的关系患者管理软件,以适应本注册表的需求。然后,我们将对我们中心的回顾性病例、我们中心的前瞻性病例以及来自全国少数中心的前瞻性病例进行登记处试点测试。最后,我们将制定可持续发展的长期计划。对于致敏患者,IKT通常是唯一可行的治疗选择,与下一个最佳选择相比,IKT为这些患者提供了显着(超过3倍)的生存益处,即在已故供体等待名单上等待相容的供体。扩大这种治疗方式不仅可以挽救生命,减少漫长的等待名单,并节省美国医疗保健系统的显着成本,而且还将刺激全国范围内移植中心,组织分型实验室和病理学实验室的扩张。虽然活体供肾移植是肾衰竭的最佳治疗方法,但每年有数千名患者拥有健康,自愿的供体,但由于与供体不相容而放弃了活体供肾移植的益处。不相容的肾移植是一种新兴的实践,患者可以从不相容的供体接受肾移植,但该领域迄今为止仅限于单中心经验,其中协议无法验证,无法开发最佳实践,并且无法完成由更有经验的中心指导新中心。该项目的目标是创建一个详细的,综合的,国家不相容肾移植登记处,将链接来自美国多个中心的临床,活检,放射学和抗体数据,以极大地改善和扩大不相容肾移植。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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ROBERT A MONTGOMERY其他文献
ROBERT A MONTGOMERY的其他文献
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{{ truncateString('ROBERT A MONTGOMERY', 18)}}的其他基金
Transplanting Lungs from Uncontrolled Donation after Circulatory Death
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Transplanting Lungs from Uncontrolled Donation after Circulatory Death
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