NCT02418169

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

3.6 years

First QC Date

April 13, 2015

Last Update Submit

April 15, 2015

Conditions

Brain InjuriesSkull Fractures

Outcome Measures

Primary Outcomes (1)

  • survival

    12 months

Study Arms (4)

retrospective, severe traumatic brain injury

All patients in 2010-2014 with severe traumatic brain injury admitted to Turku University Central Hospital (TUCH)

retrospective, craniofacial fracture

All patients in 2010-2014 with craniofacial fracture admitted to TUCH.

prospective, severe traumatic brain injury

All patients in 2015-2017 with severe traumatic brain injury admitted to Turku University Central Hospital (TUCH)

prospective, craniofacial fracture

All patients in 2015-2017 with craniofacial fracture admitted to TUCH.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with severe traumatic brain injury, patients with craniofacial fractures

You may qualify if:

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

You may not qualify if:

  • Died before admitted to hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain InjuriesSkull Fractures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 16, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

April 16, 2015

Record last verified: 2015-04