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OpenTrials
Completed

NCT Number: NCT02386865

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria for this study were:

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

Exclusion criteria

for this study were as followed:

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Glasgow Outcome Scale

    Time frame: 16 years

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Mar 12, 2015
Registry last updated
Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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