Some description

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

Key information

ISRCTN: 40935649

EudraCT number: 2015-002255-10

REC reference: 15/WA/0361

Sponsor & funder : Abertawe Broorgannwg University  Health Board       

Personnel

Chief Investigator: Prof Ian Pallister

Consultant Trauma and Orthopaedic Surgeon at Abertawe Bro Morgannwg University Health Board

Email: ian.pallister@wales.nhs.uk

Trial Manager   

 Dr Kym Thorne, Clinical Trials Manager at Swansea Trials Unit

Tel: 01792 606372

Email: k.thorne@swansea.ac.uk

http://www.swansea.ac.uk/staff/medicine/learningandteaching/thornek/

IRMINE pilot Trial Office                

Swansea Trials Unit, Floor 2, ILS2, Swansea University Medical School, Singleton Park, Swansea SA2 8PP, Email: IRMINE@swansea.ac.uk     

Design

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).

 Secondary objectives:

  • Whether the use of rhEPO reduces organ failure after severe trauma in adults.
  • The effect of rhEPO on the clinical, cellular, mitochondrial & biomolecular manifestations of the systemic inflammatory response to injury.
  • Whether human haemopoietic bone marrow responds to rhEPO after severe injury.
  • Whether rhEPO associated with an increase in thromboembolic vascular events (TVE) despite appropriate standard of care prophylaxis.
  • Whether the use of rhEPO reduces 30 day mortality after severe trauma in adults.

Timelines

Start Date: October 2016

Date 1st patient recruited: Aiming for Oct / Nov 2016

End Date:

Current recruitment overview

Number recruited so far: 2

Links to documents

Patient information sheets x 2