An observational study in Minor Head Injury, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by Massachusetts General Hospital · Observational
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:
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.
264 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's enrollment of 192 is close to the median of 200 across 115 observational studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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A total of 192 patients with mild TBIs and minor traumatic changes in head CT were identified.The most common causes of trauma were falls (72.5 %) followed by motor vehicle collisions (13.2%).
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Head CT scan showing the following minor changes
Exclusion Criteria:
Patients with head injury managed at Community Hospitals
Other: No Intervention
Patients with head injury presenting to level 1 trauma center directly
Other: No Intervention
Patients with head injury presenting at a community hospital but then getting transferred to the level 1 trauma center
Other: No Intervention
Also known as: Retrospective observational study only
Neurosurgical intervention
1. Patients requiring Hyperosmolar therapy - either mannitol or hypertonic saline. 2. Neurosurgical operation 3. Insertion of an Intracranial pressure monitor
Time frame: 30 days after admission with minor Head Injury
Death
patients who died during the index hospitalization
Time frame: 30 days after admission with minor head injury
Plan to share: Undecided
Ran from Mar 2012 to primary completion in Mar 2014, 24 months.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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