Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations

Brain Injuries Clinical Trial

Official title:

Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02418169
• Other study ID #: T74/2015
• Status: Not yet recruiting
• Phase: N/A
• First received: April 13, 2015
• Last updated: April 15, 2015
• Start date: May 2015
• Est. completion date: December 2019

Study information

• Verified date: April 2015
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study evaluates the association between traumatic brain injuries and craniofacial or/and skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary diagnostics of trauma patients.

Description:

A part of mild TBIs remains undiagnosed. Therefore the primary diagnostics of trauma patients needs to be improved. According to some studies, a part of trauma patients' concomitant injuries weren't diagnosed in the emergency room (ER) but were diagnosed later in the clinics. In addition to difficult diagnostics the treatment of these patients demands close co- operation between many specialities.

The aim of this study is to evaluate the association between TBIs and facial fractures. The real amount of facial fractures in patients with severe TBI and the clinical significance of these fractures are evaluated. Also the number of patients with facial fractures and a concomitant TBI is evaluated. The aim is to find out the amount of patients with missed diagnoses. Other aims of are to determine the effect of the type or location of a facial fracture on the in- cidence and severity of TBI. With the help of the results it would be possible to improve the comprehensive diagnostics and early treatment of patients with a facial fracture or a TBI.

The retrospective and prospective data on patients with TBI and/or facial fracture are collect- ed at Turku University Hospital. The comparison of the two groups will give information on the amount of patients with missed diagnosis of TBI or facial fracture. The results can be utilised in planning strategy for comprehensive diagnostics and treatment of the patients. In the research group the investigators have specialists in the fields of oral and maxillofacial surgery, neurol- ogy and otorhinolaryngology.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture

Exclusion Criteria:

• Died before admitted to hospital

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Fractures, Bone
• Skull Fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival		12 months	Yes