Division of Nephrology, Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Department of Neuropsychology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
BMJ Open. 2018 Dec 31;8(12):e024502. doi: 10.1136/bmjopen-2018-024502.
In the past decades, short-term results after solid organ transplantation have markedly improved. Disappointingly, this has not been accompanied by parallel improvements in long-term outcomes after transplantation. To improve graft and recipient outcomes, identification of potentially modifiable risk factors and development of biomarkers are required. We provide the rationale and design of a large prospective cohort study of solid organ transplant recipients (TransplantLines).
TransplantLines is designed as a single-centre, prospective cohort study and biobank including all different types of solid organ transplant recipients as well as living organ donors. Data will be collected from transplant candidates before transplantation, during transplantation, at 3 months, 6 months, 1 year, 2 years and 5 years, and subsequently every 5 years after transplantation. Data from living organ donors will be collected before donation, during donation, at 3 months, 1 year and 5 years after donation, and subsequently every 5 years. The primary outcomes are mortality and graft failure. The secondary outcomes will be cause-specific mortality, cause-specific graft failure and rejection. The tertiary outcomes will be other health problems, including diabetes, obesity, hypertension, hypercholesterolaemia and cardiovascular disease, and disturbances that relate to quality of life, that is, physical and psychological functioning, including quality of sleep, and neurological problems such as tremor and polyneuropathy.
Ethical approval has been obtained from the relevant local ethics committee. The TransplantLines cohort study is designed to deliver pioneering insights into transplantation and donation outcomes. The study design allows comprehensive data collection on perioperative care, nutrition, social and psychological functioning, and biochemical parameters. This may provide a rationale for future intervention strategies to more individualised, patient-centred transplant care and individualisation of treatment.
NCT03272841.
在过去几十年中，实体器官移植后的短期结果得到了显著改善。令人失望的是，这并没有伴随着移植后长期结果的平行改善。为了改善移植物和受者的结果，需要确定潜在的可改变的风险因素并开发生物标志物。我们提供了一项针对实体器官移植受者（TransplantLines）的大型前瞻性队列研究的原理和设计。
TransplantLines 被设计为一项单中心、前瞻性队列研究和生物库，包括所有不同类型的实体器官移植受者以及活体器官捐献者。数据将从移植候选人在移植前、移植期间、移植后 3 个月、6 个月、1 年、2 年和 5 年收集，并随后在移植后每 5 年收集一次。活体器官捐献者的数据将在捐献前、捐献期间、捐献后 3 个月、1 年和 5 年收集，并随后每 5 年收集一次。主要结局是死亡率和移植物失败。次要结局将是特定原因的死亡率、特定原因的移植物失败和排斥反应。三级结局将是其他健康问题，包括糖尿病、肥胖、高血压、高胆固醇血症和心血管疾病，以及与生活质量相关的紊乱，即身体和心理功能，包括睡眠质量，以及震颤和多发性神经病等神经问题。
已从相关的地方伦理委员会获得伦理批准。TransplantLines 队列研究旨在为移植和捐赠结果提供开创性的见解。该研究设计允许对围手术期护理、营养、社会和心理功能以及生化参数进行全面数据收集。这可能为未来的干预策略提供依据，以实现更个体化、以患者为中心的移植护理和治疗个体化。
NCT03272841。
