Condition category
Injury, Occupational Diseases, Poisoning
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
01/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes