A multi-centre randomised controlled trial of pre-hospital administration of packed red blood cells and freeze-dried plasma to patients with low blood pressure after major injuries.
Phase 1
- Conditions
- Hypotension after trauma, due to haemorrhageMedDRA version: 18.1Level: PTClassification code 10053476Term: Traumatic haemorrhageSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2015-001401-13-GB
- Lead Sponsor
- niversity Hospitals Birmingham NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 490
Inclusion Criteria
a. Traumatic injury
b. Pre-Hospital Emergency Medical team attend
c. Hypotension (SBP <90mmHg or absence of palpable radial pulse) believed to be due to traumatic haemorrhage.
Are the trial subjects under 18? yes
Number of subjects for this age range: 45
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
Exclusion Criteria
a. Children (known or apparently aged <16 years)
b. Refusal of blood product administration; known Jehovah’s Witness
c. Pregnancy (known or apparent)
d. Isolated head injury
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method