The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only

Alan A Garner, Kristy P Mann, Michael Fearnside, Elwyn Poynter, Val Gebski, Alan A Garner, Kristy P Mann, Michael Fearnside, Elwyn Poynter, Val Gebski

Abstract

Background: Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care.

Methods: Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score <9 (original definition), or GCS<13 and an Abbreviated Injury Scale score for the head region ≥3 (modified definition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned.

Results: 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), p<0.01, Number needed to treat =6. 338 patients met the modified definition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different.

Conclusions: This trial suggests a potential mortality reduction in patients with blunt trauma with GCS<9 receiving additional physician care (original definition only). Confirmatory studies which also address non-compliance issues are needed.

Trial registration number: NCT00112398.

Keywords: Trauma, head; comparitive system research; emergency ambulance systems, effectiveness; prehospital care, doctors in PHC; prehospital care, helicopter retrieval.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
Randomisation, enrolment and outcome data for the original criteria subgroup. Between 14 May 2005 and 14 March 2011, the study randomised 3124 incidents yielding 3696 identifiable patients. Of these, 375 patients met the original criteria for severe head injury.
Figure 2
Figure 2
Randomisation, enrolment and outcome data for the modified criteria subgroup. Between 14 May 2005 and 14 March 2011, the study randomised 3124 incidents yielding 3696 identifiable patients. Of these, 338 patients met the modified criteria for severe head injury.
Figure 3
Figure 3
Main intention-to-treat results by treatment allocated and mechanisms subgroups. OR>1 indicates higher risk in the physician treated group.
Figure 4
Figure 4
Sensitivity analyses for the primary outcome and mortality. OR>1 indicates higher risk in the physician treated group. Three missing 6-month outcomes in the Original Head Injury Criteria group (one compliant patient and two non-compliant patients).

References

    1. Franschman G, Verburg N, Brens-Heldens V, et al. . Effects of physician-based emergency medical service dispatch in severe traumatic brain injury on pre-hospital run time. Injury 2012;43:1838–42. 10.1016/j.injury.2012.05.020
    1. Garner AA, Fearnside M, Gebski V. The study protocol for the Head Injury Retrieval Trial (HIRT): a single centre randomised controlled trial of physician pre-hospital management of severe blunt head injury compared with management by paramedics. Scand J Trauma Resusc Emerg Med 2013;21:69 10.1186/1757-7241-21-69
    1. Early Management of Severe Trauma course content. Royal Australasian College of Surgeons 2013. (accessed 30 Dec 2013).
    1. Jennett B, Bond M. Assessment of outcome after severe brain damage: a practical scale. Lancet 1975;305:480–4. 10.1016/S0140-6736(75)92830-5
    1. Wilson JTL, Pettigrew LEL, Teasdale GM. Structured interviews for the glasgow outcome scale and the extended glasgow outcome scale: guidelines for their use. J Neurotrauma 1998;15:573–85. 10.1089/neu.1998.15.573
    1. Marshall LF. Neurobehavioral outcome: the neurosurgeon's perspective. In: Levin HS, Grafman J, Eisenberg HM, eds. Neurobehavioral recovery from head injury. Oxford: Oxford University Press, 1987:206–12.
    1. Clifton GL, Hayes RL, Levin HS, et al. . Outcome measures for clinical trials involving traumatically brain-injured patients: report of a conference. Neurosurgery 1992;31:975–8. 10.1227/00006123-199211000-00028
    1. Whitehead J. Sample size calculations for ordered categorical data. Stat Med 1993;12:2257–71. 10.1002/sim.4780122404
    1. Rice W. A new probability model for determining exact P-values for 2×2 tables when comparing binomial proportions. Biometrics 1988;44:1–22. 10.2307/2531892
    1. Marshall LF, Marshall SB, Klauber MR, et al. . The diagnosis of head injury requires a classification based on computed axial tomography. J Neurotrauma 1992;9:S287–292.
    1. Baxt WG, Moody P. The impact of advanced pre-hospital emergency care on the mortality of severely brain-injured patients. J Trauma 1987;27:365–9. 10.1097/00005373-198704000-00004
    1. Berlot G, La Fata C, Bacer B, et al. . Influence of pre-hospital treatment on the outcome of patients with severe blunt traumatic brain injury: a single-centre study. Eur J Emerg Med 2009;16:312–17. 10.1097/MEJ.0b013e32832d3aa1
    1. Garner A, Crooks J, Lee A, et al. . Efficacy of pre-hospital critical care teams for severe blunt head injury in the Australian setting. Injury 2001;32:455–60. 10.1016/S0020-1383(01)00013-4
    1. Klemen P, Grmec S. Effect of pre-hospital advanced life support with rapid sequence intubation on outcome of severe traumatic brain injury. Acta Anaesthesiol Scand 2006;50:1250–4. 10.1111/j.1399-6576.2006.01039.x
    1. Stewart KE, Cowan LD, Thompson DM, et al. . Association of direct helicopter versus ground transport and in-hospital mortality in trauma patients: a propensity score analysis. Acad Emerg Med 2011;18:1208–16. 10.1111/j.1553-2712.2011.01207.x

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