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document
The Toronto prehospital hypertonic resuscitation -- head injury and multiorgan dysfunction trial : feasibility study of a randomized controlled trial . OBJECTIVE The aim of the study was to evaluate the feasibility of a prehospital trial comparing hypertonic saline and dextran ( HSD ) with normal saline ( NS ) in blunt head injury patients . DESIGN The study used a double blind randomized trial . SETTING The study was conducted in air and land emergency medical services and 2 trauma centers serving a population of 4 million people . PATIENTS The study population consisted of head injured , blunt trauma adult patients with a Glasgow Coma Scale of lower than 9 . INTERVENTIONS We used 250 mL of HSD vs NS given within 4 hours of the accident . MEASUREMENTS The specific objectives were to assess protocol-related logistical issues , randomization , HSD safety , and follow up rates and to obtain survival and neurocognitive end point estimates . MAIN RESULTS Of 132 eligible patients , 113 were randomized . Nineteen eligible patients were missed because of lack of time ( 9 [ 22 % ] ) , paramedic discretion ( 3 [ 7 % ] ) , the paramedic forgot ( 6 [ 15 % ] ) , and the paramedic refused ( 1 [ 2 % ] ) . Randomization compliance was 96 % ( 109/113 ) . Four randomized cases met exclusion criteria : penetrating trauma ( 1 ) , cardiac arrest ( 2 ) , and fall from standing ( 1 ) . Three randomized patients were excluded from the final analysis : 2 patients received less than 50 mL of study solution due to an interstitial intravenous line and 1 lost randomization identification . Fifty patients ( 47 % ) were randomized to HSD and 56 ( 53 % ) to NS . Mean injury severity score was 32.7 for HSD and 32.6 for NS . There was no difference in length of stay , Sequential Organ Failure Assessment maximum , Multiple Organ Dysfunction Score maximum , delta Multiple Organ Dysfunction Score , or Apache scores . Initial head scans scored 3 or higher by Marshall classification for 12 HSD and 11 NS patients . Zero adverse events occurred , and follow-up for the primary outcome was 100 % . Alive at 30 days for HSD and NS , respectively , was 70 % ( 35/50 ) and 75 % ( 42/56 ) and at discharge was 68 % ( 34/50 ) and 73 % ( 41/56 ) . Only 49.3 % ( 37/77 ) of surviving patients consented to follow-up at 4 months and 89 % ( 33/37 ) completed the assessment . Disability rating scale ( median , interquartile range ) was 3 ( 0 , 6 ) for HSD and was 0 ( 0 , 6 ) for NS . Glasgow Outcome Scale Evaluation was higher than 4 for HSD ( 12/12 [ 100 % ] ) and NS ( 15/21 [ 72 % ] ) . Functional Independence Measure ( mean , SD ) was 62 ( 37 ) for HSD and 80 ( 32 ) for NS . CONCLUSIONS It is feasible to conduct a prehospital randomized controlled trial with HSD for treatment of blunt trauma patients with head injuries ; however , consent for neurofunctional outcomes in this cohort is problematic and threatens the feasibility of definitive trials using these potentially meaningful end points .
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Intervention_Pharmacological
hypertonic saline and dextran ( HSD )
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Intervention_Pharmacological
normal saline ( NS
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Intervention_Pharmacological
250 mL of HSD
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Intervention_Pharmacological
NS
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Intervention_Pharmacological
HSD
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Outcome_Physical
assess protocol-related logistical issues
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Outcome_Physical
randomization
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Outcome_Other
HSD safety ,
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Outcome_Mental
follow up rates
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Outcome_Mortality
survival
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Outcome_Physical
neurocognitive end point estimates
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Outcome_Physical
Mean injury severity score
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Outcome_Other
length of stay
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Outcome_Physical
Sequential Organ Failure Assessment maximum , Multiple Organ Dysfunction Score maximum , delta Multiple Organ Dysfunction Score , or Apache scores
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Outcome_Other
Initial head scans
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Outcome_Adverse-effects
adverse events
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Outcome_Mortality
Alive at 30 days
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Outcome_Physical
Disability rating scale
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Outcome_Physical
Glasgow Outcome Scale Evaluation
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Outcome_Physical
Functional Independence Measure
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Participant_Condition
resuscitation -- head
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Participant_Sample-size
4 million people .
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Participant_Condition
adult
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Participant_Condition
Glasgow Coma
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Participant_Sample-size
132 eligible patients
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Participant_Sample-size
113
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Participant_Condition
blunt trauma patients with head injuries ;