Rationale and design of TransplantLines: a prospective cohort study and biobank of solid organ transplant recipients

Michele F Eisenga, Antonio W Gomes-Neto, Marco van Londen, Aaltje L Ziengs, Rianne M Douwes, Suzanne P Stam, Maryse C J Osté, Tim J Knobbe, Niek R Hessels, Anne M Buunk, Coby Annema, Marion J Siebelink, Emoke Racz, Jacoba M Spikman, Frank A J A Bodewes, Robert A Pol, Stefan P Berger, Gea Drost, Robert J Porte, Henri G D Leuvenink, Kevin Damman, Erik A M Verschuuren, Vincent E de Meijer, Hans Blokzijl, Stephan J L Bakker, Michele F Eisenga, Antonio W Gomes-Neto, Marco van Londen, Aaltje L Ziengs, Rianne M Douwes, Suzanne P Stam, Maryse C J Osté, Tim J Knobbe, Niek R Hessels, Anne M Buunk, Coby Annema, Marion J Siebelink, Emoke Racz, Jacoba M Spikman, Frank A J A Bodewes, Robert A Pol, Stefan P Berger, Gea Drost, Robert J Porte, Henri G D Leuvenink, Kevin Damman, Erik A M Verschuuren, Vincent E de Meijer, Hans Blokzijl, Stephan J L Bakker

Abstract

Introduction: 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).

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: NCT03272841.

Keywords: cohort study; survival; transplant medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Overview of different health problems that arise in the long term after transplantation, physical, psychological and social.
Figure 2
Figure 2
Flow chart of the different visits in the TransplantLines study. At every study visit, biobank, general tests and questionnaires will be performed. Specifically addition at each timepoints; at time of transplantation, perioperative residual material will be collected. At 3 months after transplantation, cognitive protocol will be performed. At 6 months, physical protocol will be carried out. At 12 months, randomisation to physical or cognitive protocol will occur. At 2 years after transplantation, a limited set of tests will be executed. Follow-up will be performed every 5 years.
Figure 3
Figure 3
Overview of the three main pillars of the TransplantLines study, that is, questionnaires, biobank and tests. The collection of data in these pillars at multiple timepoints will allow investigation of whether biomarkers at baseline can better predict the occurrence of adverse outcomes and whether correction could possibly result in an improved survival.

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