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Minor Head InjuryNCT04143347

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

An observational study of Minor Head Injury, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Minor Head Injury
How many people
192 participants
Where
1 siteUnited States
Study dates
1 Mar 2012to 1 May 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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%).

Who may be able to join

  • 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
Show all 12Show fewer
  • 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 -

Who cannot join

  • 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 -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Being tested
No Intervention
Keywords
TBI, Traumatic Brain injury, Transfer, Blunt
Medical subject headings
Craniocerebral Trauma, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    Also called Retrospective observational study only

Study groups in NCT04143347
Study groupRoleWhat they receive
Community Hospitals - CHPatients with head injury managed at Community Hospitals
Receives: Other: No Intervention
Level 1 Trauma Center - L1TCPatients with head injury presenting to level 1 trauma center directly
Receives: Other: No Intervention
TransferPatients with head injury presenting at a community hospital but then getting transferred to the level 1 trauma center
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurosurgical intervention

    1. Patients requiring Hyperosmolar therapy - either mannitol or hypertonic saline.
    2. Neurosurgical operation
    3. Insertion of an Intracranial pressure monitor

    Measured: 30 days after admission with minor Head Injury

Secondary outcomes (1)
  1. Death

    patients who died during the index hospitalization

    Measured: 30 days after admission with minor head injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start1 Mar 2012
  3. Primary completion1 Mar 2014
  4. Study completion1 May 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04143347
Sponsor's protocol ID
2014P001407
Status last verified
Oct 2019
First submitted
15 Oct 2019
Last updated
29 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Minor Head Injury, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurosurgical intervention (time frame: 30 days after admission with minor Head Injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04143347, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.

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