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Clinical Trials/NCT03272841
NCT03272841
Unknown
Not Applicable

TransplantLines: the Transplantation Biobank

University Medical Center Groningen1 site in 1 country3,000 target enrollmentStarted: June 2015Last updated:

Overview

Phase
Not Applicable
Enrollment
3,000
Locations
1
Primary Endpoint
Graft failure / mortality

Overview

Brief Summary

TransplantLines is an observational cohort study in all solid transplant recipients, i.e. kidney, heart, lung, liver, small bowel and pancreas. In this study we will gather questionnaires about topics affecting transplant recipients, e.g. QoL, work and physical capacity. Moreover, we will collect multiple urine and blood samples for analysis. Additionally, we will store hair, nails and faeces from the transplant recipients. Next to this, we will perform physical capacity tests and cognitive tests.

Detailed Description

The last decades, the acute period after transplantation has markedly improved due to improved tissue-matching techniques and better immunosuppressive drugs. However, nowadays the major aim after transplantation is the long-term patient and graft survival which are still poor, where half of the RTR looses their graft after 10 years. With TransplantLines we are setting up an extensive biobank to improve the long-term survival after transplantation. Moreover, we are one of the few studies to collect across transplant specialities. Like mentioned in the brief summary, extensive questionnaires will be send to participants prior to the visit containing multiple questionnaires (e.g. SF-36, WHODAS, PQ-SGA etc.). During the visit, we will collect multiple blood samples who will be taken during the regularly visit to the clinician. Moreover, two tubes from 24-hour urine collection will be collected, faeces, hair and nails will be stored. Finally, physical tests and cognitive tests will be performed with the participants (e.g. 2-min walking test, 4m walking test, timed-up-and-go test etc.).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Solid organ transplant recipients

Exclusion Criteria

  • Age younger than 18 years old
  • Cognitive dysfunction

Outcomes

Primary Outcomes

Graft failure / mortality

Time Frame: Untill 2020

Development of graft failure or mortality in the transplant recipients

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. dr. S.J.L. Bakker, MD, PhD

Internist-nephrologist

University Medical Center Groningen

Study Sites (1)

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