Risk Factors Predicting Prognosis and Outcome of Elderly Patients With Isolated Traumatic Brain Injury

NCT ID: NCT02386865

Last Updated: 2015-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. patients aged 65 years and older and
2. acute severe TBI defined by an Abbreviated Injury Scale (AIS-head) score of ≥ 3 for the head region.

Exclusion Criteria

1. oral intubation prior to ED-admission;
2. no details of the time of injury (e.g. chronic subdural hematomas) and
3. any concomitant injuries.
4. 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Julian Joestl

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30390698 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1/2008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Inhaled Nitric Oxide in Brain Injury
NCT03260569 COMPLETED PHASE3
The PIT-TBI Pilot Study
NCT02480985 UNKNOWN NA