Contact information
Type
Scientific
Primary contact
Prof John Nicholl
ORCID ID
Contact details
School of Health and Related Research
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 222 5201/2
j.nicholl@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 93/23/19
Study information
Scientific title
Acronym
Study hypothesis
The initiation of intravenous fluid replacement in injured patients at the accident scene is becoming a routine procedure. It has been assumed that early volume replacement in a bleeding patient will result in the patient arriving at hospital in a better haemodynamic state than if no fluids are given. However, some non-randomised studies of trauma patients and one quasi-randomised study of patients with severe bleeding injuries have begun to cast doubt on this assumption.
In the UK most on-scene fluid therapy is given by ambulance-service paramedics acting in accordance with their protocols. We therefore conducted a pragmatic study to compare the effects of two different fluid protocols, one usually with fluid administration and one usually without, used by paramedics.
Ethics approval
Approval from 16 local research ethics committees
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Injury, occupational diseases, poisoning: Other injury, occupational diseases, poisoning
Intervention
With approval from 16 local research ethics committees, paramedics in two ambulance services were randomly allocated to one of two treatment protocols for the prehospital use of intravenous fluids in adult trauma patients. Paramedics who had been qualified for at least 1 year were randomised to an initial treatment protocol using a simple random-number generator. Approximately half way through the trial the paramedics were crossed over to the alternative protocol. Cluster randomised controlled. trial.
Protocol A: intravenous fluids were administered at the incident scene to all adult trauma patients who under current procedures the paramedic would consider starting on intravenous fluids.
Protocol B: fluids were withheld until arrival at hospital, unless the time to hospital was likely to be over 1 hour.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Death, complications, general health status (measured using the Short Form with 36 items (SF-36) questionnaire), processes of care and costs were measured up to 6 months post-incident.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/1995
Overall trial end date
31/01/1998
Reason abandoned
Eligibility
Participant inclusion criteria
Trauma patients aged 16 years or over who died or stayed in hospital for three or more nights and who were attended by a paramedic crew randomised to a treatment protocol were included in the study.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
1309
Participant exclusion criteria
Patients with burns, poisoning, asphyxiation, minor uncomplicated skin or skeletal injuries, isolated fractured neck of femur, or who were pregnant were excluded.
Recruitment start date
01/12/1995
Recruitment end date
31/01/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Health and Related Research
Sheffield
S1 4DA
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2000 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/11109030
Publication citations
-
HTA monograph
Turner J, Nicholl J, Webber L, Cox H, Dixon S, Yates D, A randomised controlled trial of prehospital intravenous fluid replacement therapy in serious trauma., Health Technol Assess, 2000, 4, 31, 1-57.