NCT02530749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

4.7 years

First QC Date

August 10, 2015

Last Update Submit

July 9, 2019

Conditions

Brain Tumors

Keywords

SurgeryFrailty

Outcome Measures

Primary Outcomes (1)

  • Number of patients with a Complication risk

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

    30 days

Secondary Outcomes (2)

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

    30 days

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

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Brain NeoplasmsFrailty

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • D. R. Ormond, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 21, 2015

Study Start

April 1, 2014

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

July 11, 2019

Record last verified: 2019-07

Locations

US(1)