Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot Study

This study is not yet open for participant recruitment.
Verified November 2013 by Population Health Research Institute
Sponsor:
Information provided by (Responsible Party):
P.J. Devereaux, Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01984385
First received: November 7, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

Hip VISION (Pilot Study) is a Prospective Observational Cohort Study to evaluate the incidence of overall and cause-specific mortality among consecutive patients aged ≥ 18 years presenting with hip fracture to the Juravinski Hospital of the Hamilton Health Sciences. This pilot study will assess the feasibility of a larger prospective international cohort study. After eligibility has been confirmed and informed consent has been obtained, participants will be registered in the study. Troponin level, complete blood counts and serum creatinine level will be collected at day 1 through day 7 post admission. CAM instrument will be employed at admission and once daily post admission DAY 1 THROUGH DAY 7. FIM Instrument will be administered within 72 hours of admission to establish pre-fracture functional independence and disability. Patients will be contacted by research personnel by telephone 30 days after study registration.


Condition
Hip Fractures

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot Study

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • Total and cause specific mortality in hip fracture patients at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Major complications within 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Composite of vascular mortality, nonfatal MI, nonfatal stroke, nonfatal PE, sepsis, and life-threatening bleeding.


Secondary Outcome Measures:
  • Nonfatal myocardial infarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Nonfatal myocardial injury after noncardiac surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Nonfatal pulmonary embolism [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Nonfatal infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Nonfatal bleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Nonfatal stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • New congestive heart failure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • New atrial fibrillation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Nonfatal cardiac arrest [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Deep vein thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • New acute renal failure requiring dialysis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cardiac catheterization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • PCI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • CABG [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • CAM days 1-7 post-op [ Time Frame: 1-7 days post-op ] [ Designated as safety issue: No ]
  • Implant failure or periprosthetic fracture [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Re-operation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • New nursing home residence [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • First mobilization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • FIM (motor function) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with a hip fracture

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with hip fracture

Criteria

Inclusion Criteria:

  1. Patients aged ≥ 18 years with hip fractures (i.e. fractures involving the subcapital, femoral neck, or intertrochanteric regions), treated either operatively or non-operatively
  2. Mechanism of injury consistent with either:

    1. A fall from a standing height or;
    2. Another mechanism of injury which, in the clinical judgment of an orthopedic surgeon, would impart the same or less traumatic energy as a fall from a standing height

Exclusion Criteria:

  1. Patients with fractures isolated to the proximal femoral shaft, with no involvement of the intertrochanteric, femoral neck, or subcapital region
  2. Patients with hip fractures resulting from high energy mechanisms, such as motor vehicle accidents or falls from a substantial height
  3. Patient who refuse 30-day or 6-month follow up
  4. Patients who refuse to consent either by themselves or through a substitute decision-maker (for patients unable to consent, we will use a deferred consent process, as described below).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01984385

Contacts
Contact: Yongning Ou, MSc 905-527-4322 ext 40496 yongning.ou@phri.ca
Contact: Shirley Pettit 905-527-4322 ext 40526 shirley.pettit@phri.ca

Locations
Canada, Ontario
Juravinski Hospital and Cancer Centre (HHS) Not yet recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Krysten Gregus    905-521-2100 ext 44156    hendersonk@hhsc.ca   
Principal Investigator: Mohit Bhandari, PhD         
Sponsors and Collaborators
Population Health Research Institute
Investigators
Principal Investigator: PJ Devereaux, PhD Population Health Research Institute
  More Information

No publications provided

Responsible Party: P.J. Devereaux, MD, PhD, FRCP(C), Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01984385     History of Changes
Other Study ID Numbers: HipVISION Pilot - 2013
Study First Received: November 7, 2013
Last Updated: November 14, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 17, 2014