Brain InjuriesNCT02475226
Cases With Traumatic and Non Traumatic Brain Damage Treated in the Intensive Care
An observational study of Brain Injuries, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality. In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed to evaluate the relationship between mortality and the distribution of reason for and resulting type of brain damage and to… 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?
- type of the brain injury
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2015to May 2015
- 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: a total of 1004 patients treated in the ICU in a 2-year period were retrospectivly reviewed. 135 patients, determined with traumatic or nontraumatic brain damage, with a more than 24-hour stay in the ICU, included the study.
Who may be able to join
- Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay.
Who cannot join
- Patients admitted less than 24 hour.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Umraniye Education and Research Hospital
Istanbul, Turkey
About this study
Official title: Distribution and Mortality Factors of Cases With Traumatic and Non Traumatic Brain Damage Treated in Intensive Care; Retrospective Clinical Trial
Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality. In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed to evaluate the relationship between mortality and the distribution of reason for and resulting type of brain damage and to determine other factors affecting mortality.
Read the detailed description
After local ethics committee approval, a total of 1004 patients treated in the ICU in a 2-year period were retrospectively reviewed. 135 patients, determined with traumatic or nontraumatic brain damage, with a more than 24-hour stay in the ICU, included the study. Reasons for brain damage were determined as brain damage associated with pure head trauma (Group HT), head trauma accompanying general body trauma (Group HT+GBT) and spontaneous haemorrhage (Group SH). The type of brain damage was defined from the radiological diagnosis as subarachnoid haemorrhage, intracranial haemorrhage (ICH), subdural haematoma(SDH), epidural haematoma(EDH), skull fracture, brain contusion or a combination of these (COM).
- Conditions
- Brain Injuries
- Being tested
- type of the brain injury
- Keywords
- Traumatic Brain Injury, Brain Damage, Mortality, C10.228.140.199
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
type of the brain injuryOther
epidural hematoma
type of the brain injuryOther
subdural hematoma
type of the brain injuryOther
subarachnoid hematoma
type of the brain injuryOther
intraparenchymal hematoma
type of the brain injuryOther
scull fracture
type of the brain injuryOther
brain contusion
| Study group | Role | What they receive |
|---|---|---|
| Patients with body and head trauma | type of the brain injury in patients with brain damage associated both general body and head trauma Receives: Other: type of the brain injury | |
| Patients with pure head trauma | type of the brain injury in patients with brain damage associated pure head trauma Receives: Other: type of the brain injury | |
| Patients with spontaneous hemorrhage | type of the brain injury in Patients with brain damage associated spontaneous hemorrhage Receives: Other: type of the brain injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients by brain damage types
distribution of the patients with brain damage over the brain damage reasons
Measured: 2 years
Secondary outcomes (1)
Number of factors effecting the mortality
duration time of intubation, duration time in the ICU, APACHE scores, GCS scores.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- Nurten Bakan, MD, Study chair, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475226
- Sponsor's protocol ID
- GK7
- Status last verified
- Jun 2015
- First submitted
- 15 Jun 2015
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sacco S, Marini C, Toni D, Olivieri L, Carolei A. Incidence and 10-year survival of intracerebral hemorrhage in a population-based registry. Stroke. 2009 Feb;40(2):394-9. doi: 10.1161/STROKEAHA.108.523209. Epub 2008 Nov 26.
PubMed 19038914Schwarz S, Hafner K, Aschoff A, Schwab S. Incidence and prognostic significance of fever following intracerebral hemorrhage. Neurology. 2000 Jan 25;54(2):354-61. doi: 10.1212/wnl.54.2.354.
PubMed 10668696
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution and Mortality Factors of Cases With Traumatic and Non Traumatic Brain Damage Treated in Intensive Care; Retrospective Clinical Trial
- ClinicalTrials.gov ID
- NCT02475226
- Acronym / sponsor ID
- GK7
- Conditions
- Brain Injuries
- Keywords
- Traumatic Brain Injury, Brain Damage, Mortality, C10.228.140.199
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Apr 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Jun 2015 (estimated)
- 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.
Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality. In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed to evaluate the relationship between mortality and the distribution of reason for and resulting type of brain damage and to determine other factors affecting mortality.
Detailed description
After local ethics committee approval, a total of 1004 patients treated in the ICU in a 2-year period were retrospectively reviewed. 135 patients, determined with traumatic or nontraumatic brain damage, with a more than 24-hour stay in the ICU, included the study. Reasons for brain damage were determined as brain damage associated with pure head trauma (Group HT), head trauma accompanying general body trauma (Group HT+GBT) and spontaneous haemorrhage (Group SH). The type of brain damage was defined from the radiological diagnosis as subarachnoid haemorrhage, intracranial haemorrhage (ICH), subdural haematoma(SDH), epidural haematoma(EDH), skull fracture, brain contusion or a combination of these (COM).
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with body and head trauma | – | Other: type of the brain injurytype of the brain injury in patients with brain damage associated both general body and head trauma |
| Patients with pure head trauma | – | Other: type of the brain injurytype of the brain injury in patients with brain damage associated pure head trauma |
| Patients with spontaneous hemorrhage | – | Other: type of the brain injurytype of the brain injury in Patients with brain damage associated spontaneous hemorrhage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- a total of 1004 patients treated in the ICU in a 2-year period were retrospectivly reviewed. 135 patients, determined with traumatic or nontraumatic brain damage, with a more than 24-hour stay in the ICU, included the study.
Key inclusion criteria (1 listed)
- Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay.
Key exclusion criteria (1 listed)
- Patients admitted less than 24 hour.
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 |
|---|---|---|
| type of the brain injuryepidural hematoma | Other | Patients with body and head trauma, Patients with pure head trauma, Patients with spontaneous hemorrhage |
| type of the brain injurysubdural hematoma | Other | Patients with body and head trauma, Patients with pure head trauma, Patients with spontaneous hemorrhage |
| type of the brain injurysubarachnoid hematoma | Other | Patients with body and head trauma, Patients with pure head trauma, Patients with spontaneous hemorrhage |
| type of the brain injuryintraparenchymal hematoma | Other | Patients with body and head trauma, Patients with pure head trauma, Patients with spontaneous hemorrhage |
| type of the brain injuryscull fracture | Other | Patients with body and head trauma, Patients with pure head trauma, Patients with spontaneous hemorrhage |
| type of the brain injurybrain contusion | Other | Patients with body and head trauma, Patients with pure head trauma, Patients with spontaneous hemorrhage |
Primary outcome
number of patients by brain damage types
Time frame: 2 years
distribution of the patients with brain damage over the brain damage reasons
1 secondary outcome
Number of factors effecting the mortality
Time frame: 2 years
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 18 Jun 2015.
- Results publication: PubMed 19038914Sacco S, Marini C, Toni D, Olivieri L, Carolei A. Incidence and 10-year survival of intracerebral hemorrhage in a population-based registry. Stroke. 2009 Feb;40(2):394-9. doi: 10.1161/STROKEAHA.108.523209. Epub 2008 Nov 26.
- Results publication: PubMed 10668696Schwarz S, Hafner K, Aschoff A, Schwab S. Incidence and prognostic significance of fever following intracerebral hemorrhage. Neurology. 2000 Jan 25;54(2):354-61. doi: 10.1212/wnl.54.2.354.
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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.
Nurten Bakan, MD study chair
Umraniye Education and Research Hospital
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 Umraniye Education and Research Hospital 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 1 inclusion and 1 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 18 Jun 2015. 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?
number of patients by brain damage types (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475226, which also lists 2 linked publications.
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 18 Jun 2015; AzTrials last refreshed its copy on 30 Oct 2026.