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CompletedNCT04143347Updated Oct 29, 2019

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

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

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
192
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Minor Head Injury

Keywords

  • TBI
  • Traumatic Brain injury
  • Transfer
  • Blunt
03

In context

Craniocerebral Trauma

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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%).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Blunt Trauma to Head
  2. Patients with Glasgow Coma Scale (GCS) 13-15
  3. Head CT scan showing the following minor changes

    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 defined as 2-3 small bubbles of intracranial air
    6. linear or minimally depressed skull fracture
  4. Patients who had more than one of the above findings were also included
  5. Patients on aspirin were included
  6. Patients who were intoxicated with alcohol were included if their GCS could still be assessed as being between 13-15 -

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
192 participants (actual)
Patient registry
No

Groups and cohorts

  • Community Hospitals - CH

    Patients with head injury managed at Community Hospitals

    Other: No Intervention

  • Level 1 Trauma Center - L1TC

    Patients with head injury presenting to level 1 trauma center directly

    Other: No Intervention

  • Transfer

    Patients with head injury presenting at a community hospital but then getting transferred to the level 1 trauma center

    Other: No Intervention

Interventions

  • OtherNo Intervention

    Also known as: Retrospective observational study only

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Death

    patients who died during the index hospitalization

    Time frame: 30 days after admission with minor head injury

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Study locations

1 site
  • Massachusetts General hospital
    Boston, Massachusetts 02114, United States
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References and documents

Publications

  • Sugerman DE, Xu L, Pearson WS, Faul M. Patients with severe traumatic brain injury transferred to a Level I or II trauma center: United States, 2007 to 2009. J Trauma Acute Care Surg. 2012 Dec;73(6):1491-9. doi: 10.1097/TA.0b013e3182782675. PubMed 23188242 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2012 to primary completion in Mar 2014, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2019
First posted
Oct 29, 2019
StartActual
Mar 1, 2012
Primary completionActual
Mar 1, 2014
CompletionActual
May 1, 2014
Last update
Oct 29, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04143347
Responsible party
Sanjay Gupta, M.D. (Instructor in Surgery, Massachusetts General Hospital) — Principal investigator
First posted
Oct 29, 2019
Start date
Mar 1, 2012
Primary completion
Mar 1, 2014
Completion
May 1, 2014
Last update
Oct 29, 2019

Study contacts

Sanjay Gupta, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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