Minor Head Injury Clinical Trial
Official title:
Outcome of Patients With Mild Head Injury and Presence of an Acute Traumatic Abnormality on CT Scan of Head
Background: Patients with mild blunt traumatic brain injury (TBI) are frequently transferred
to Level 1 trauma centers (L1TC) if they have any positive finding of any acute intracranial
injury identified on a CT scan of the head. The hypothesis for the study is that patients
with such injuries and minor changes on the Head CT scan can be safely managed at community
hospitals (CH).
Methods: Patients with blunt, mild TBI (defined as a GCS 13-15 at presentation) presenting to
CH, L1TC, and transferred from CH to L1TC between March, 2012 and February, 2014 were
included. Minor changes on head CT were defined as: 1) epidural hematoma<2mm; 2) subarachnoid
hemorrhage<2mm; 3) subdural hematoma<4mm; 4) intraparenchymal hemorrhage<5mm; 5) minor
pneumocephalus; or 6) linear or minimally depressed skull fracture. TBI-specific
interventions were defined as intracranial pressure monitor placement, administration of
hyperosmolar therapy, or neurosurgical operation. Three groups of patients were compared: 1)
those receiving treatment at CH, 2) those transferred from CH to L1TC, and 3) those
presenting directly to L1TC.
The primary endpoint was the need for TBI-specific intervention and secondary outcome was
death of any patient.
Methods
The trauma registries at all participating centers were searched for patients who developed
mild TBIs following blunt trauma and were directly admitted either to L1TC, or CH, or
transferred from CH to L1TC. Patients with Glasgow Coma Scale (GCS) equal to or greater than
13 and a positive head CT scan for minor injuries were included in the study. Minor CT
findings were defined as: 1) an epidural hematoma less than 2 mm thick, 2) a subarachnoid
hemorrhage measuring less than 2 mm, 3) a subdural hematoma less than 4 mm thick, 4) an
intraparenchymal hemorrhage measuring less than 5 mm, 5) minor pneumocephalus, or 6) linear
or minimally depressed skull fracture. Patients with multiple findings were also included so
long as the above criteria were met. Patients were also included patients if they were taking
aspirin or if they were intoxicated with alcohol as long as their GCS could still be assessed
to be between 13-15. Patients with more severe CT scan findings were excluded. Patients were
also excluded if they were younger than 18 years of age, presented with open skull fractures,
were intubated or hemodynamically unstable upon presentation, or had prior history of
bleeding diathesis. Finally, patients with injuries in other areas of the body with an
abbreviated injury score (AIS) > 2 were excluded.
After obtaining approval by the Institutional Review Board, data of interest was
retrospectively collected from one LITC and four CH. This was done by using the trauma
registries and reviewing individual medical charts. Collected data included baseline
demographics (e.g. age and gender), variables related to the blunt trauma (e.g. mechanism of
injury, injury severity score [ISS], and AIS scores), baseline comorbidities, vital signs and
GCS on arrival to the emergency department, CT scan findings and whether a repeat CT scan of
the head was performed, the administration of blood products, hospital and intensive care
unit (ICU) length of stay, as well as in-hospital complication and mortality rates.
Three groups of patients were compared:
1. those who were admitted and received definitive treatment at one of the four CH
2. those who initially presented at CH but were subsequently transferred to L1TC and
3. those who presented directly to the L1TC.
The primary endpoint of the study was the need for TBI-specific interventions in these 3
groups. TBI-specific intervention was defined as a neurosurgical operation, insertion of an
intracranial pressure (ICP) monitor, or administration of hyperosmolar therapy. The secondary
endpoint was mortality.
Statistical analysis was performed using the STATA software (version 13.1). Numerical
variables are reported as medians with interquartile ranges (25th to 75th percentile), and
categorical ones as frequencies and percentages. The Kruskal Wallis non-parametric test was
used to compare the numerical variables and the chi-square or Fisher's exact test to compare
the categorical variables as appropriate. The multivariable logistic regression analyses to
identify independent predictors of TBI-specific interventions or independent risk factors for
mortality and overall morbidity could not be performed, given the rarity of these events in
the patient population. p-value of less than 0.05 was defined as the level of statistical
significance.
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