Outcome of Patients With Mild Head Injury and Presence of an Acute Traumatic Abnormality on CT Scan of Head

Completed

Conditions studied: Minor Head Injury

In brief

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.

Key facts

Study ID

NCT04143347

Run by

Massachusetts General Hospital

People needed

192

Starts

2012-03-01

Expected to finish

2014-05-01

Last updated by the study team

2019-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Blunt Trauma to Head
• Patients with Glasgow Coma Scale (GCS) 13-15
• Head CT scan showing the following minor changes
• an epidural hematoma less than 2 mm thick
• a subarachnoid hemorrhage measuring less than 2 mm
• a subdural hematoma less than 4 mm thick
• an intraparenchymal hemorrhage measuring less than 5 mm
• minor pneumocephalus defined as 2-3 small bubbles of intracranial air
• linear or minimally depressed skull fracture
• Patients who had more than one of the above findings were also included
• Patients on aspirin were included
• Patients who were intoxicated with alcohol were included if their GCS could still be assessed as being between 13-15 -

You may not qualify if…

• Patients with more severe CT scan findings than those noted above
• Less than 18 years of age
• Open skull fractures
• Intubated patients
• Hemodynamically unstable upon presentation
• Prior history of bleeding diathesis
• Patients with severe extracranial injuries - defined as Abbreviated Injury Scale (AIS) greater than or equal to 3 in any other body region -

Where it is running

• Massachusetts General hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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