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NCT Number: NCT02530749

Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients

Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been evaluated. This study aims to determine if frailty predicts neurosurgical complications in brain tumor patients and enhances current perioperative risk models.

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Key information

Conditions

Brain Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Frailty Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

Preoperative risk assessment is important, but inexact, in older patients because physiologic reserves are difficult to measure. This also makes an important difference related to brain tumor patients, who may be burdened with systemic disease, alterations in cognition, or affected by other comorbidities. When assessing quality of life for brain tumor patients, having a better predictor of postsurgical outcome would be beneficial in appropriately counseling these patients. Frailty is thought to estimate physiologic reserves, and its use has been found to predict postoperative complications, length of stay, and discharge to a skilled or assisted-living facility in neurosurgical patients. Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been evaluated. This study aims to determine if frailty predicts neurosurgical complications in brain tumor patients and enhances current perioperative risk models.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult
  • Ambulatory (able to walk)
  • Scheduled for neurosurgical resection of brain tumor

Exclusion criteria

  • Parkinson disease
  • Previous stroke
  • Taking: carbidopa/levodopa, donepezil hydrochloride, or antidepressants

Treatment and study plan

Primary outcomes

  1. Number of patients with a Complication risk

    Time frame: 30 days

    Number of patients with a complication risk based on a Hopkins Frailty Score (HFS).

Secondary outcomes

  1. Length of stay based on a Hopkins Frailty Score (HFS).

    Time frame: 30 days

    Number of patients with a prolonged length of stay based on a Hopkins Frailty Score (HFS).

  2. Number of patients Discharge to a skilled or assisted-living facility

    Time frame: 30 days

    Number of patients discharged to a skilled or assisted-living facility based on a Hopkins Frailty Score (HFS).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Aug 21, 2015
Registry last updated
Jul 11, 2019

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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