Brain InjuriesNCT02386865
Risk Factors Predicting Prognosis and Outcome of Elderly Patients With Isolated Traumatic Brain Injury
An observational study of Brain Injuries, run by Medical University of Vienna.
Trial summary
Although several prognostic models have been developed to predict outcome for patients with severe traumatic brain injury (TBI), currently no study describes the impact of respiratory failure during Emergency Department treatment on mortality in a population of elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Brain Injuries
- How many people
- 292 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2012
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: : All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were identified from the trauma registry. Stepwise logistic regression analysis was used to identify risk factors for a poor prognosis and outcome.
Who may be able to join
None listed.
Who cannot join
- oral intubation prior to ED-admission;
- no details of the time of injury (e.g. chronic subdural hematomas) and
- any concomitant injuries.
- Patients who received oral intubation prior to ED-admission were excluded due to the high variability of indications other than respiratory failure or secondary neurological decline (e.g. intubation required for aspiration protection) that may not be necessarily related to TBI induced secondary respiratory failure.
About this study
Although several prognostic models have been developed to predict outcome for patients with severe traumatic brain injury (TBI), currently no study describes the impact of respiratory failure during Emergency Department treatment on mortality in a population of elderly patients. The purpose of the present study was to evaluate factors predicting poor outcome with special emphasis on the impact of respiratory failure on mortality in elderly patients with isolated severe TBI.
All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were identified from the trauma registry. Stepwise logistic regression analysis was used to identify risk factors for a poor prognosis and outcome.
Read more
The logistic regression found the following variables influencing the mortality: respiratory failure (p<0.0005; OR: 9.369), pupillary response (p<0.0212, OR: 3.393) and ISS score (p<0.0001, OR:1.179). A significant (p<0.0001) increased risk of death was also found for patients with a midline shift >15 mm.
The present study predicts a strong correlation between respiratory failure, pathological pupillary response, a higher ISS and substantial midline shift with poor outcomes in elderly patients sustaining an isolated severe TBI.
- Conditions
- Brain Injuries
- Medical subject headings
- Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Management
Interventions, Critical Care Procedures, Blood units, e.g. that were done within the first 3 hours after trauma within the emergency trauma room
Measured: 16 years
Secondary outcomes (1)
Glasgow Outcome Scale
Measured: 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Joestl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386865
- Sponsor's protocol ID
- 1/2008
- Status last verified
- Mar 2015
- First submitted
- 6 Mar 2015
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ostermann RC, Joestl J, Tiefenboeck TM, Lang N, Platzer P, Hofbauer M. Risk factors predicting prognosis and outcome of elderly patients with isolated traumatic brain injury. J Orthop Surg Res. 2018 Nov 3;13(1):277. doi: 10.1186/s13018-018-0975-y.
PubMed 30390698
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Predicting Prognosis and Outcome of Elderly Patients With Isolated Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02386865
- Acronym / sponsor ID
- 1/2008
- Conditions
- Brain Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Mar 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.
Although several prognostic models have been developed to predict outcome for patients with severe traumatic brain injury (TBI), currently no study describes the impact of respiratory failure during Emergency Department treatment on mortality in a population of elderly patients. The purpose of the present study was to evaluate factors predicting poor outcome with special emphasis on the impact of respiratory failure on mortality in elderly patients with isolated severe TBI.
All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were identified from the trauma registry. Stepwise logistic regression analysis was used to identify risk factors for a poor prognosis and outcome.
The logistic regression found the following variables influencing the mortality: respiratory failure (p<0.0005; OR: 9.369), pupillary response (p<0.0212, OR: 3.393) and ISS score (p<0.0001, OR:1.179). A significant (p<0.0001) increased risk of death was also found for patients with a midline shift >15 mm.
The present study predicts a strong correlation between respiratory failure, pathological pupillary response, a higher ISS and substantial midline shift with poor outcomes in elderly patients sustaining an isolated severe TBI.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- : All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were identified from the trauma registry. Stepwise logistic regression analysis was used to identify risk factors for a poor prognosis and outcome.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- oral intubation prior to ED-admission;
- no details of the time of injury (e.g. chronic subdural hematomas) and
- any concomitant injuries.
- Patients who received oral intubation prior to ED-admission were excluded due to the high variability of indications other than respiratory failure or secondary neurological decline (e.g. intubation required for aspiration protection) that may not be necessarily related to TBI induced secondary respiratory failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Emergency Department Management
Time frame: 16 years
Interventions, Critical Care Procedures, Blood units, e.g. that were done within the first 3 hours after trauma within the emergency trauma room
1 secondary outcome
Glasgow Outcome Scale
Time frame: 16 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 12 Mar 2015.
- Derived from this study: PubMed 30390698Ostermann RC, Joestl J, Tiefenboeck TM, Lang N, Platzer P, Hofbauer M. Risk factors predicting prognosis and outcome of elderly patients with isolated traumatic brain injury. J Orthop Surg Res. 2018 Nov 3;13(1):277. doi: 10.1186/s13018-018-0975-y.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by Medical University of Vienna.
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 0 inclusion and 4 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 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Emergency Department Management (time frame: 16 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 NCT02386865, which also lists 1 linked publication.
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 12 Mar 2015.