NCT06183749

Brief Summary

The primary outcome of this study was to identify mortality predictors/risk factors affecting mortality and secondary outcome was to determine the distribution of brain injury types and other parameters according to type of trauma in patients with TBI treated in anesthesia-reanimation tertiary ICU.

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
194

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

29 days

First QC Date

December 12, 2023

Last Update Submit

December 21, 2023

Conditions

Keywords

brain injuries, traumatic, mortality prediction

Outcome Measures

Primary Outcomes (1)

  • mortality predictor

    Identification of those that are associated with mortality among the parameters examined

    through study completion, an average of 2 months

Study Arms (2)

group 1general body trauma (Group 1)

Diagnosed as traumatic brain injury due to general body trauma neurosurgery in the emergency department and hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit and those who have been in intensive care within the past two years.

Other: hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit

isolated head trauma (Group 2).

diagnosed as traumatic brain injury due isolated head trauma neurosurgery in the emergency department and hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit and those who have been in intensive care within the past two years.

Other: hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit

Interventions

diagnosed as traumatic brain injury by neurosurgery in the emergency department and hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit and receivied appropriate necessary treatment

group 1general body trauma (Group 1)isolated head trauma (Group 2).

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients over the age of 18, diagnosed as traumatic brain injury by neurosurgery in the emergency department and hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit

You may qualify if:

  • patients over the age of 18,
  • diagnosed as traumatic brain injury by neurosurgery in the emergency department .hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit

You may not qualify if:

  • Failure to obtain institutional Ethics Committee approval Failure to obtain patients records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Injuries

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SPECIALIST, MD,

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 28, 2023

Study Start

February 1, 2024

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

December 28, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share