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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386865
• Other study ID #: 1/2008
• Status: Completed
• Phase: N/A
• First received: March 6, 2015
• Last updated: March 11, 2015
• Start date: January 2008
• Est. completion date: January 2012

Study information

• Verified date: March 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: January 2012
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

The inclusion criteria for this study were:

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 for this study were as followed:

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Brain Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	16 years	No
Secondary	Glasgow Outcome Scale		16 years	No