RePHILL (Resuscitation with Pre-HospItaL bLood products)

  • Research type

    Research Study

  • Full title

    A Multi-Centre Randomised Controlled Trial of Pre-Hospital Blood Product Administration versus Standard Care for Traumatic Haemorrhage

  • IRAS ID

    179484

  • Contact name

    Gavin Perkins

  • Contact email

    g.d.perkins@warwick.ac.uk

  • Sponsor organisation

    University Hospitals Birmingham NHS Foundation Trust

  • Eudract number

    2015-001401-13

  • Duration of Study in the UK

    3 years, 8 months, 30 days

  • Research summary

    This trial will investigate whether giving blood products (red blood cells and freeze-dried plasma) to badly injured adult patients, before reaching hospital improves their clinical condition and survival. Patients with major bleeding are currently given clear fluids but military and civilian research suggests that survival increases if hospital patients receive blood products instead.

    The best treatment for bleeding patients before reaching hospital is uncertain. Giving too much fluid to improve blood pressure can increase bleeding. Therefore only small amounts of clear fluid are given. Some pre-hospital doctors now give red blood cells instead. Animal research suggests that this is better than clear fluids, and that adding plasma is better still. Some clinical studies support this, however other research has found no benefit. No good quality evidence exists to show that giving blood products before hospital, saves lives.

    In this trial, 490 injured patients with major bleeding will be divided randomly into two groups. Pre-hospital medical teams will give one group current “best practice” (small volumes of clear fluid). The other group will receive blood products. At hospital, we will see which group has better survival and whether blood flow to body tissues shortly after hospital admission is improved. We will assess blood flow by measuring lactic acid. High lactic acid levels are associated with poor survival.
    The main outcomes will be whether the patients, who received blood products, survive and clear lactic acid from their tissues faster, indicating better blood flow around the body. We will also examine blood pressure, heart rate, blood clotting and whether patients need organ support on intensive care.

    This trial could improve treatment of injured patients (if blood products are beneficial) or avoid wasting blood products (if they are not).

  • REC name

    South Central - Oxford C Research Ethics Committee

  • REC reference

    15/SC/0691

  • Date of REC Opinion

    15 Dec 2015

  • REC opinion

    Further Information Favourable Opinion