Brain InjuriesNCT04555772
Evaluation of Factors That Cause Secondary Brain Damage on Mortality and Morbidity in Patients Undergoing Emergency Surgery Due to Head Trauma.
An observational study of Brain Injuries, run by Turkish Society of Anesthesiology and Reanimation at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- factors evaluation
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2018to 30 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- pediatric patients
- patients that operated after 24 hour of admission
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Brain Injuries
- Being tested
- factors evaluation
- Keywords
- secondary brain damage, electrolyte imbalance, head trauma
- Medical subject headings
- Brain Injuries, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
factors evaluationOther
They investigated mortality and morbidity in patients who underwent emergency operation within 24 hours after traumatic brain injury.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Group | Patients who had been treated and recovered physically and gained cognitive functions completely. Receives: Other: factors evaluation | |
| Sequel Group | Patients who could not gain their physical and cognitive functions. Receives: Other: factors evaluation | |
| Exitus Group | Patients who did not respond to the treatments and lost their lives within 28 days of admission. Receives: Other: factors evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start11 Jan 2018
- Primary completion11 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Anesthesiology and Reanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555772
- Sponsor's protocol ID
- uludagunineuroanesthesia
- Status last verified
- Sep 2020
- First submitted
- 29 Jul 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Factors That Cause Secondary Brain Damage on Mortality and Morbidity in Patients Undergoing Emergency Surgery Due to Head Trauma.
- ClinicalTrials.gov ID
- NCT04555772
- Acronym / sponsor ID
- uludagunineuroanesthesia
- Conditions
- Brain Injuries
- Keywords
- secondary brain damage, electrolyte imbalance, head trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Turkish Society of Anesthesiology and ReanimationUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Group | – | Other: factors evaluationPatients who had been treated and recovered physically and gained cognitive functions completely. |
| Sequel Group | – | Other: factors evaluationPatients who could not gain their physical and cognitive functions. |
| Exitus Group | – | Other: factors evaluationPatients who did not respond to the treatments and lost their lives within 28 days of admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- pediatric patients
- patients that operated after 24 hour of admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| factors evaluationThey investigated mortality and morbidity in patients who underwent emergency operation within 24 hours after traumatic brain injury. | Other | Exitus Group, Healthy Group, Sequel Group |
Primary outcome
mortality and morbidity in patients who underwent emergency operation within 24 hours after traumatic brain injury
Time frame: 5 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by Turkish Society of Anesthesiology and Reanimation at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality and morbidity in patients who underwent emergency operation within 24 hours after traumatic brain injury (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.