A study comparing pre-hospital administration of packed red blood cells and freeze-dried plasma with administration of normal saline in patients with low blood pressure after major injuries

Plain English summary of protocol

Background and study aims
Major trauma accounts for a significant number of deaths worldwide, and is one of the most frequent causes of death in people under the age of 40. A large number of these deaths are caused by major bleeding as a result of the trauma (traumatic haemorrhage). Patients with traumatic heamorrhage are currently given clear fluids but military and civilian research suggests that survival increases if hospital patients receive blood products (red blood cells and freeze-dried plasma) 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 studies in humans support this however other research has found no benefit. There is currently no good quality evidence exists to show whether giving blood products before hospital, saves lives. The aim of this study is to find out whether giving blood products to badly injured adult patients, before reaching hospital improves their clinical condition and survival.

Who can participate?
Patients believed to be over the age of 16 who have sustained a serious injury leading to major blood loss.

What does the study involve?
Participants are randomly allocated to one of two groups at the scene of the emergency. Those in the first group receive fluids through a drip, with up to four bags of normal saline (salt water). Those in the second group receive two units of concentrated red blood cells and two units of freeze dried plasma (straw like fluid that makes up the liquid part of blood). Participants in both groups are followed up for 30 days to find out if any patients died (of their injuries or otherwise), as well as the speed they are able to clear lactic acid from their tissues (indicator of good blood flow). Blood pressure, heart rate, blood clotting and whether patients need organ support are also monitored while they are on intensive care.

What are the possible benefits and risks of participating?
There are no guaranteed direct benefits involved with participating in this study however the blood product treatment could be shown to be more effective than standard treatment. There are no notable risks involves for those participating in this study.

Where is the study run from?
Pre-hospital emergency medicine and major trauma centres in the West Midlands, Dorset & Somerset and in the East of England (UK)

When is the study starting and how long is it expected to run for?
October 2015 to April 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Miss Gemma Slinn, rephill@trials.bham.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centres

Results and Publications

Study outputs

Editorial Notes

02/09/2024: Publication reference added.
11/03/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
26/10/2020: The public contact's details have been changed and the plain English summary updated accordingly.
06/03/2020: The following changes have been made:
1. Publication reference added.
2. The publication and dissemination plan has been updated.
3. The intention to publish date has been changed from 30/04/2021 to 31/05/2022.
10/02/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/01/2020 to 31/12/2020.
2. The overall trial end date has been changed from 30/04/2020 to 31/05/2021.
3. The trial website has been added.
02/04/2019: The condition has been changed from "Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies; UKCRC code/ Disease: Injuries/ Certain early complications of trauma" to "Traumatic haemorrhage" following a request from the NIHR.
18/07/2016: Verified study status with principal investigator.