Introduction: The role of various neuroprotective agents in severe traumatic brain injury (STBI) has been a subject of research. The aim of the present study is to examine efficacy of Progesterone and hypothermia, alone or in combination, in improving neurological outcome in STBI. The preliminary results of the trial are presented.
Methods: A Randomized placebo controlled trial involving 250 patients of STBI has been ongoing at our center. Total of 64 patients have been recruited. All adult patients with GCS 4-8 were randomized < 8 hours of injury into A) Placebo, B)-Progesterone, C)- Hypothermia + Placebo, D)-Hypothermia +Progesterone, and E)- Hypothermia. The primary endpoint of study was Glasgow outcome score (GOS), while the secondary endpoints were Mortality and Functional Independence Measure (FIM) at 6 months. The serum levels of biomarkers (S100, IL-6, NSE, Progesterone, Estrogen, Pyruvate Dehydrogenase, Complex I and IV) were analyzed at admission and after one week.
Results: The overall mortality was 28%, lowest in Hypothermia (16.6%) and highest in progesterone group (38.4%). Overall, good outcome was seen in 62%, while another 38% had poor outcome. The progesterone group had worst outcome, while hypothermia group had best outcome at 6 months. The serum levels of all biomarkers were significantly decreased at 1 week as compared to on admission in all groups. The band intensity of PDH, Complex I and Complex IV were higher on the 7th day after treatment.
Conclusions: these preliminary data suggests a beneficial role of hypothermia in improving the outcome of STBI.
Patient Care: This study will give the hope for new treatment for severe traumatic brain injury patients with better functional outcome and less mortality.
Learning Objectives: By the end of this session the participants should, be able to learn the role of newer neuroprotective agents like progesterone and hypothermia in improving the functional outcome in patients with Severe traumatic brain injury