Inflammatory Response in Major INjury & recombinant human Erythropoietin (IRMINE) - a pilot study
A pilot blinded randomised placebo controlled trial of rhEPO in adult trauma critical care
Access to trial processes
Randomisation (authorised users only – password required) - Link to https://stu.swan.ac.uk/randirmine
If unable to access this link, please phone 01792 606600 to access the STU Helpdesk.
Trial database (authorised users only – password required; allow pop-ups in browser) – IRMINE Pilot MACRO Database
EudraCT number: 2015-002255-10
REC reference: 15/WA/0361
Sponsor & funder : Abertawe Broorgannwg University Health Board
Chief Investigator: Prof Ian Pallister
Consultant Trauma and Orthopaedic Surgeon at Abertawe Bro Morgannwg University Health Board
Dr Kym Thorne, Clinical Trials Manager at Swansea Trials Unit
Tel: 01792 606372
IRMINE pilot Trial Office
Swansea Trials Unit, Floor 2, ILS2, Swansea University Medical School, Singleton Park, Swansea SA2 8PP, Email: IRMINE@swansea.ac.uk
This is a randomised, blinded, single centre placebo-controlled pilot trial to evaluate the feasibility of conducting a larger scale, multi-centre trial to evaluate the impact of administering recombinant human erythropoietin (rhEPO) on adults who have experienced severe trauma and been admitted to an Intensive Therapy Unit (ITU) compared with those administered saline as a placebo.
Type of study eg RCT
Prospective 1:1 randomised feasibility trial.
Sample size: Up to 10
Objectives: Primary objective: To test the trial design and logistics, in preparation for a multi-centre randomised controlled trial (RCT).
Start Date: October 2016
Date 1st patient recruited: Aiming for Oct / Nov 2016
Current recruitment overview
Number recruited so far: 2
Links to documents
Patient information sheets x 2