H-Guard Pilot Safety Evaluation
Research type
Research Study
Full title
A within-patient, pilot assessment of the safety and performance of H-Guard as a priming solution for use in the set-up of blood tubing sets and dialysers prior to use in haemodialysis patients.
IRAS ID
322526
Contact name
Leonard Ebah
Contact email
Sponsor organisation
Invizius Ltd
Duration of Study in the UK
0 years, 3 months, 25 days
Research summary
This is a first-in-human (pilot) investigation designed to assess the acute safety of H-Guard, a device solution containing a novel ancillary biologic, for use as a priming solution in the set up of haemodialysis blood tubing sets and dialysers in patients routinely undergoing dialysis. In addition to acute safety this study would explore as an exploratory measure, the potential utility of the ancillary biologic, to protect patients from inflammation arising from an immune reaction between the patients blood and dialyser using biomarkers in blood.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0097
Date of REC Opinion
7 Jun 2023
REC opinion
Further Information Favourable Opinion