Expired Study
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Aurora, Colorado 80045


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

14-0579


NCT ID:

NCT02530749


Secondary ID:


Study Acronym:


Brief Title:

Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients


Official Title:

Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

265


Enrollment Type:

Actual


Overall Contact Information

Official Name:D. R. Ormond, MD
Principal Investigator
University of Colorado, Denver

Study Dates

Start Date:April 2014
Completion Date:March 2019
Completion Type:Actual
Primary Completion Date:December 2018
Primary Completion Type:Actual
Verification Date:July 2019
Last Changed Date:July 9, 2019
First Received Date:August 10, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of patients with a Complication risk
Time Frame:30 days
Safety Issues:False
Description:Number of patients with a complication risk based on a Hopkins Frailty Score (HFS).
Outcome Type:Secondary Outcome
Measure:Length of stay based on a Hopkins Frailty Score (HFS).
Time Frame:30 days
Safety Issues:False
Description:Number of patients with a prolonged length of stay based on a Hopkins Frailty Score (HFS).
Outcome Type:Secondary Outcome
Measure:Number of patients Discharge to a skilled or assisted-living facility
Time Frame:30 days
Safety Issues:False
Description:Number of patients discharged to a skilled or assisted-living facility based on a Hopkins Frailty Score (HFS).

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Samples and Retentions

Study Population: This study includes patients 18 years and older with a history of brain tumor scheduled for elective resection of tumor. Patients have to be ambulatory and be able to complete the examination and obtain a Hopkins Frailty Score.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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