NCT04555772

Brief Summary

Traumatic brain injury is combination damage that occurs as a result of a chain reaction of various metabolic events that develop after primary damage caused by trauma. Pathological events such as lactic acidosis, electrolyte imbalance, increased inflammation that occur during traumatic brain injury leads to poor prognosis in patients. The retrospective study was conducted to investigate the effect of factors that may cause secondary damage, especially electrolyte imbalance and blood glucose levels, on mortality and morbidity in patients undergoing emergency surgery due to head trauma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 11, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

July 29, 2020

Last Update Submit

September 14, 2020

Conditions

Keywords

secondary brain damageelectrolyte imbalancehead trauma

Outcome Measures

Primary Outcomes (1)

  • mortality and morbidity in patients who underwent emergency operation within 24 hours after traumatic brain injury

    It seems that secondary damage caused by metabolic events like eletrolyte imbalance in patients with head trauma should always keep in mind. If they encounter these situations, they should treat the patient and do replacements immediately.

    5 years

Study Arms (3)

Healthy Group

Patients who had been treated and recovered physically and gained cognitive functions completely.

Other: factors evaluation

Sequel Group

Patients who could not gain their physical and cognitive functions.

Other: factors evaluation

Exitus Group

Patients who did not respond to the treatments and lost their lives within 28 days of admission.

Other: factors evaluation

Interventions

They investigated mortality and morbidity in patients who underwent emergency operation within 24 hours after traumatic brain injury.

Exitus GroupHealthy GroupSequel Group

Eligibility Criteria

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

they collect data of 108 patients who admitted to Bursa Uludag University hospital between 2013 and 2018 and were diagnosed with traumatic brain injury and operated within the first 24 hours after admission.

You may qualify if:

  • patients who admitted to Bursa Uludag University hospital between 2013 and 2018
  • patients diagnosed with traumatic brain injury and operated within the first 24 hours after admission

You may not qualify if:

  • pediatric patients
  • patients that operated after 24 hour of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa uludag university

Bursa, 16285, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brain InjuriesCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2020

First Posted

September 21, 2020

Study Start

January 11, 2018

Primary Completion

January 11, 2019

Study Completion

January 30, 2019

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Locations