Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT04619732
Eligibility Criteria:
Inclusion Criteria:
* All organs to be used in the study must be intended for transplantation and not already rejected/discarded.
* All organs must be sourced from deceased donors through NHSBT in the normal course of clinical activity.
* Kidneys must come from marginal or 'imperfect' donors according to current clinical criteria. This typically indicates an age of 60 and over, or 50 and over with one or more premorbid conditions, including renal impairment, cerebrovascular disease, and hypertension.
Exclusion Criteria:
* Organs from living donors are excluded.
* Organs from young healthy donors are excluded.
* Organs will be excluded if on the assessment of the clinical team they are not suitable for hypothermic machine perfusion. This indicates organs that have arrived with visible defects, or fall well outside the team's standard criteria for clinical acceptability (excessive time in transit, excessive warm ischaemia time, excessive cold ischaemia time, very poor pre-morbid donor condition).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04619732
Study Brief:
Protocol Section:
NCT04619732