Abstract 104: The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi -Organ Dysfunction Trial (TOPHR HIT)
Study Goal: To evaluate the feasibility of a prehospital randomized controlled trial comparing 250 ml of Hypertonic Saline and Dextran (HSD ) to Normal Saline (NS) for head injured adult trauma patients GCS<9. Specific objectives were to evaluate the protocol related logistical issues; randomization, HSD safety, follow-up rates and to define the best primary outcome.
Methods: Double blind randomized trial with paramedic administration of a 250 ml solution within 4 hours of the incident. The primary outcome was survival to 30 days; secondary outcomes were Disability Rating Scale (DRS) and Glasgow Outcome Score Extended (GOSE) at 4 months. The study was conducted with waiver of consent for the primary outcome. Patients consented for telephone follow up of neurofunctional outcomes.
Results: Of 132 eligible patients; 113 were randomized. Nineteen eligible patients were missed; lack of time (9, [22%]); paramedic discretion (3, [7%]); forgot (6,[15%]); refused (1, [2%]). Randomization compliance was 96% (109/113). Four randomized cases met exclusion criteria; (1) penetrating trauma, (2) cardiac arrest and (1) fall from standing. Three randomized patients were excluded from the final analysis; (2) patients received < 50 mls 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 ISS was 32.7 for HSD and 32.6 for NS. Initial head scans scored ≥3 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 was 70% (35/50) and 75% (42/56) respectively and 68% in both groups at discharge. Only 48% (37/77) of surviving patients consented to follow up at 4 months and 89% (33/37) completed the assessment; DRS (median, interquartile range) for HSD; 3 (0,6) and NS 0 (0,6); GOSE>4 for HSD 12/12 (100%) and NS 15/21 (72%).
Conclusions: It is feasible to conduct a prehospital randomized controlled trial with HSD for treatment of blunt trauma patients with head injuries. Acquiring consent for neurofunctional outcomes in this cohort is problematic and threatens the feasibility of definitive trials employing these potentially meaningful endpoints.