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.

RCT Entities:   Population Interventions Outcomes