Brain TumorsNCT02530749
Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients
An observational study of Brain Tumors, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumors
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult
- Ambulatory (able to walk)
- Scheduled for neurosurgical resection of brain tumor
Who cannot join
- Parkinson disease
- Previous stroke
- Taking: carbidopa/levodopa, donepezil hydrochloride, or antidepressants
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Brain Tumors
- Keywords
- Surgery, Frailty
- Medical subject headings
- Brain Neoplasms, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a Complication risk
Number of patients with a complication risk based on a Hopkins Frailty Score (HFS).
Measured: 30 days
Secondary outcomes (2)
Length of stay based on a Hopkins Frailty Score (HFS).
Number of patients with a prolonged length of stay based on a Hopkins Frailty Score (HFS).
Measured: 30 days
Number of patients Discharge to a skilled or assisted-living facility
Number of patients discharged to a skilled or assisted-living facility based on a Hopkins Frailty Score (HFS).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startApr 2014
- Primary completionDec 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D. R. Ormond, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530749
- Sponsor's protocol ID
- 14-0579
- Status last verified
- Jul 2019
- First submitted
- 10 Aug 2015
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT02530749
- Acronym / sponsor ID
- 14-0579
- Conditions
- Brain Tumors
- Keywords
- Surgery, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult
- Ambulatory (able to walk)
- Scheduled for neurosurgical resection of brain tumor
Key exclusion criteria (3 listed)
- Parkinson disease
- Previous stroke
- Taking: carbidopa/levodopa, donepezil hydrochloride, or antidepressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Length of stay based on a Hopkins Frailty Score (HFS).
Time frame: 30 days
Number of patients Discharge to a skilled or assisted-living facility
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. R. Ormond, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a Complication risk (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.