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

NCT04143347 | Completed

• 1 other identifier: 2014P001407
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Minor Head Injury

Keywords

TBI; Traumatic Brain injury; Transfer; Blunt

Outcome Measures

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

  30 days after admission with minor Head Injury

Secondary Outcomes (1)

• Death

  30 days after admission with minor head injury

Study Arms (3)

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

No Intervention OTHER

Also known as: Retrospective observational study only

Community Hospitals - CH; Level 1 Trauma Center - L1TC; Transfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%).

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 -

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 23188242 BACKGROUND

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Study Officials

• Sanjay Gupta, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Surgery

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 29, 2019
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

US (1)