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
Phase 3
Completed
- Conditions
- Traumatic haemorrhageInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN62326938
- Lead Sponsor
- niversity Hospitals Birmingham NHS Foundation Trust
- Brief Summary
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29193548 protocol (added 06/03/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35271808/ (added 11/03/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38224557/ (added 02/09/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 432
Inclusion Criteria
1. Traumatic injury
2. Pre-Hospital Emergency Medical team attend
3. Hypotension (SBP <90mmHg or absence of palpable radial pulse) believed to be due to traumatic haemorrhage
Exclusion Criteria
1. Children (known or apparently aged <16 years)
2. Refusal of blood product administration; known Jehovah’s Witness
3. Pregnancy (known or apparent)
4. Isolated head injury
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. 1. Episode mortality is measured by whether or not the patient is still alive up to 30 days post injury up to 30 days post injury<br>2. Lactate clearance is measured by obtaining a lactate measurement at randomisation and a repeat measurement two hours post-randomisation
- Secondary Outcome Measures
Name Time Method