Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients

Completed

• Conditions: Brain Tumors

• Registration Number: NCT02530749
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-21
• Primary Completion: 2018-12
• Study Completion: 2019-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with a Complication risk	30 days	Number of patients with a complication risk based on a Hopkins Frailty Score (HFS).

Secondary Outcome Measures

Name	Time	Method
Length of stay based on a Hopkins Frailty Score (HFS).	30 days	Number of patients with a prolonged length of stay based on a Hopkins Frailty Score (HFS).
Number of patients Discharge to a skilled or assisted-living facility	30 days	Number of patients discharged to a skilled or assisted-living facility based on a Hopkins Frailty Score (HFS).

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States