Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Crit Care Resusc. 2013 Sep;15(3):234-40.
Despite efforts to increase organ donation, there remain critical shortages in organ donors and organs procured per donor. Our trial is a large-scale, multicentre, randomised controlled trial in brain-dead donors, to compare protocolised care (using minimally invasive haemodynamic monitoring) with usual care. We describe the study design and discuss unique aspects of doing research in this population.
Our study will randomise brain-dead patients to protocolised or usual care. The primary end point is the number of organs transplanted per donor. Secondary end points include number of transplantable organs per donor, recipient 6-month hospital-free survival time, and the relationship between the level of interleukin-6 and the number and usability of organs transplanted. The primary analysis will be an intention-to-treat analysis; secondary analyses include modified intention-to-treat and as-treated analyses. The study will also compare the ratio of observed to expected number of organs transplanted per donor, by treatment arm, as a secondary end point. Preplanned subgroup analyses include restriction to extended criteria donors, and donors older or younger than 65 years.
Several unique challenges for study design and execution can be seen in our trial, and it should generate results that will inform and influence the fields of organ donation and transplantation.
尽管为增加器官捐献者数量做出了努力，但器官捐献者和每个捐献者获取的器官仍存在严重短缺。我们的试验是一项针对脑死亡供体的大规模、多中心、随机对照试验，旨在比较方案化护理（使用微创血流动力学监测）与常规护理。我们描述了研究设计，并讨论了在这一人群中进行研究的独特方面。
我们的研究将随机分配脑死亡患者接受方案化护理或常规护理。主要终点是每个供者移植的器官数量。次要终点包括每个供者可移植器官的数量、受者 6 个月无住院生存率，以及白细胞介素 6 水平与移植器官数量和可用性之间的关系。主要分析将是意向治疗分析；次要分析包括修改的意向治疗和实际治疗分析。该研究还将通过治疗组比较观察到的与预期每个供者移植器官数量的比例，作为次要终点。预先计划的亚组分析包括限制在扩展标准供体，以及年龄大于或小于 65 岁的供体。
我们的试验中可以看到一些独特的研究设计和实施挑战，它应该产生结果，为器官捐献和移植领域提供信息和影响。
