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.
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
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:
- those who were admitted and received definitive treatment at one of the four CH
- those who initially presented at CH but were subsequently transferred to L1TC and
- 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.
- Conditions
- Minor Head Injury
- 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 group | Role | What they receive |
|---|---|---|
| Community Hospitals - CH | Patients with head injury managed at Community Hospitals Receives: Other: No Intervention | |
| Level 1 Trauma Center - L1TC | Patients with head injury presenting to level 1 trauma center directly Receives: Other: No Intervention | |
| Transfer | Patients 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.
Neurosurgical intervention
- Patients requiring Hyperosmolar therapy - either mannitol or hypertonic saline.
- Neurosurgical operation
- Insertion of an Intracranial pressure monitor
Measured: 30 days after admission with minor Head Injury
Secondary outcomes (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.
- First posted29 Oct 2019
- Study start1 Mar 2012
- Primary completion1 Mar 2014
- Study completion1 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Minor Head InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Gupta, M.D., Massachusetts General Hospital
- Investigators
- Sanjay Gupta, MD, Principal investigator, Massachusetts General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Patients With Mild Head Injury and Presence of an Acute Traumatic Abnormality on CT Scan of Head
- ClinicalTrials.gov ID
- NCT04143347
- Acronym / sponsor ID
- 2014P001407
- Conditions
- Minor Head Injury
- Keywords
- TBI, Traumatic Brain injury, Transfer, Blunt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 1 Mar 2014 (actual)
- Study completion
- 1 May 2014 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- those who were admitted and received definitive treatment at one of the four CH
- those who initially presented at CH but were subsequently transferred to L1TC and
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community Hospitals - CH | – | Other: No InterventionPatients with head injury managed at Community Hospitals |
| Level 1 Trauma Center - L1TC | – | Other: No InterventionPatients with head injury presenting to level 1 trauma center directly |
| Transfer | – | Other: No InterventionPatients with head injury presenting at a community hospital but then getting transferred to the level 1 trauma center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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%).
Key inclusion criteria (12 listed)
- Blunt Trauma to Head
- Patients with Glasgow Coma Scale (GCS) 13-15
- Head CT scan showing the following minor changes
- Patients who had more than one of the above findings were also included
- Patients on aspirin were included
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionAlso: Retrospective observational study only | Other | Community Hospitals - CH, Level 1 Trauma Center - L1TC, Transfer |
Primary outcome
Neurosurgical intervention
Time frame: 30 days after admission with minor Head Injury
1. Patients requiring Hyperosmolar therapy - either mannitol or hypertonic saline. 2. Neurosurgical operation 3. Insertion of an Intracranial pressure monitor
1 secondary outcome
Death
Time frame: 30 days after admission with minor head injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Background: PubMed 23188242Sugerman 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.
- Individual participant dataSharing planned: Undecided
Related trials for Minor Head Injury
RecruitingObservational study
Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma
Craniocerebral Trauma, Brain Injuries, Traumatic
Active, not recruitingObservational study
Delayed Intracranial Hemorrhages in Patients With Minor Head Injury on Anticoagulant or Dual Anti-platelet Therapy
Hemorrhage Brain
Enrolling by invitation
The "Concussion or Brain Bleed" Trial
Head Injury
Not yet recruitingObservational study
Using Routine Inflammatory and Metabolic Blood Tests (Bedside Included) to Predict Brain Injury in Children After Minor Head Trauma
Brain Injury Traumatic Mild
RecruitingObservational study
Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ?
Head Injury Trauma, Emergencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Gupta, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
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.