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Cited by 141Transplantation: Methods and OutcomesOrgan Transplantation Techniques and OutcomesOrgan Donation and Transplantation

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

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Eisenga, Michele F, Gomes-Neto, Antonio W, van Londen, Marco, Ziengs, Aaltje L, Douwes, Rianne M, Stam, Suzanne P, Osté, Maryse C J, Knobbe, Tim J, Hessels, Niek R, Buunk, Anne M, Annema, Coby, Siebelink, Marion J, Racz, Emoke, Spikman, Jacoba M, Bodewes, Frank A J A, Pol, Robert A, Berger, Stefan P, Drost, Gea, Porte, Robert J, Leuvenink, Henri G D, Damman, Kevin, Verschuuren, Erik A M, de Meijer, Vincent E, Blokzijl, Hans, Bakker, Stephan J L·2018·BMJ Open
DOI 10.1136/bmjopen-2018-024502PMC PMC6318532
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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.

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Figure 1 Overview of different health problems that arise in the long term after transplantation, physical, psychological and social.
Figure 1 Overview of different health problems that arise in the long term after transplantation, physical, psychological and social.CC BY-NC · PubMed Central
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 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.CC BY-NC · PubMed Central
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.
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.CC BY-NC · PubMed Central

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Research works printed but not linked: 3

  1. Schmand B , Lindeboom J , van Harskamp F . Nederlandse leestest voor volwassenen: handleiding (NLV). Amsterdam: Pearson Assessment and Information B.V, 1992.
  2. Wechsler D . WAIS-IV-NL: Wechsler Adult Intelligence Scale - Fourth Edition - Nederlandstalige bewerking: Technische handleiding en Afname en scoringshandleiding. Amsterdam: Pearson Assessment and Information B.V, 2012.
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Metadata

Authors
Eisenga, M. F., Gomes-Neto, A. W., van Londen, M., Ziengs, A. L., Douwes, R. M., Stam, S. P., Osté, M. C. J., Knobbe, T. J., Hessels, N. R., Buunk, A. M., Annema, C., Siebelink, M. J., Racz, E., Spikman, J. M., Bodewes, F. A. J. A., Pol, R. A., Berger, S. P., Drost, G., Porte, R. J., Leuvenink, H. G. D., Damman, K., Verschuuren, E. A. M., de Meijer, V. E., Blokzijl, H., & Bakker, S. J. L.
Affiliations
University Medical Center Groningen (NL)
Corresponding author
Eisenga, Michele F
ORCID
Venue
BMJ Open
Publisher
BMJ
Published
2018-12
Volume
8
Issue
12
Pages
e024502
ISSN
2044-6055 (ISSN-L)
DOI
10.1136/bmjopen-2018-024502
PMC
PMC6318532
OpenAlex
W2908082263
Cited by
141
References
77
Citations by year
2026: 20 · 2025: 23 · 2024: 30 · 2023: 17 · 2022: 18 · 2021: 17 · 2020: 11 · 2019: 5
FWCI
8.57
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • BMJ Open (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, cc-by-nc)
  • HighWire Press Open Archive (submittedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, cc-by-nc)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
Funders
Astellas BV
Topics
  • Health Sciences › Medicine › Surgery › Transplantation: Methods and Outcomes
  • Health Sciences › Medicine › Surgery › Organ Transplantation Techniques and Outcomes
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Organ Donation and Transplantation
Keywords
solid organ transplantation, living donor, transplant recipients, biobanks, graft failure, mortality, graft rejection, long-term outcomes, risk factors, biomarkers, post-transplant complications, diabetes mellitus, cardiovascular disease, quality of life, sleep disorders, neurological complications
MeSH terms
Graft Survival, Humans, Netherlands, Tissue and Organ Procurement, Prospective Studies, Research Design, Time Factors, Tissue Banks, Organ Transplantation, Living Donors, Observational Studies as Topic, Transplant Recipients

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