TY - JOUR
T1 - Rationale and design of TransplantLines
T2 - a prospective cohort study and biobank of solid organ transplant recipients
AU - Eisenga, Michele F.
AU - Gomes-Neto, Antonio W.
AU - van Londen, Marco
AU - Ziengs, Aaltje L.
AU - Douwes, Rianne M.
AU - Stam, Suzanne P.
AU - Oste, Maryse C. J.
AU - Knobbe, Tim J.
AU - Hessels, Niek R.
AU - Buunk, Anne M.
AU - Annema, Coby
AU - Siebelink, Marion J.
AU - Racz, Emoke
AU - Spikman, Jacoba M.
AU - Bodewes, Frank A. J. A.
AU - Pol, Robert A.
AU - Berger, Stefan P.
AU - Drost, Gea
AU - Porte, Robert J.
AU - Leuvenink, Henri G. D.
AU - Damman, Kevin
AU - Verschuuren, Erik A. M.
AU - de Meijer, Vincent E.
AU - Blokzijl, Hans
AU - Bakker, Stephan J. L.
N1 - © 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.
PY - 2018/12
Y1 - 2018/12
N2 - 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.
AB - 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.
KW - QUALITY-OF-LIFE
KW - LONG-TERM
KW - ALLOGRAFT SURVIVAL
KW - UNITED-STATES
KW - MISSING DATA
KW - IMMUNOSUPPRESSIVE DRUGS
KW - SKIN AUTOFLUORESCENCE
KW - LUNG TRANSPLANTATION
KW - SYMPTOM EXPERIENCE
KW - GAIT SPEED
U2 - 10.1136/bmjopen-2018-024502
DO - 10.1136/bmjopen-2018-024502
M3 - Article
C2 - 30598488
SN - 2044-6055
VL - 8
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e024502
ER -