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Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients

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ClinicalTrials.gov Identifier: NCT02530749
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Brain Tumors

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.

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Study Type : Observational
Actual Enrollment : 265 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients
Study Start Date : April 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530749


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: D. R. Ormond, MD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02530749    
Other Study ID Numbers: 14-0579
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Keywords provided by University of Colorado, Denver:
Surgery
Frailty
Additional relevant MeSH terms:
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Brain Neoplasms
Frailty
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes