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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01984385
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : October 6, 2015
Information provided by (Responsible Party):
P.J. Devereaux, Population Health Research Institute

Brief Summary:
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 10 post admission. CAM instrument will be employed at admission and once daily post admission day 1 through day 10. 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 or disease
Hip Fractures

Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
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
Study Start Date : December 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Patients with a hip fracture

Primary Outcome Measures :
  1. Total and cause specific mortality in hip fracture patients at 30 days [ Time Frame: 30 days ]
  2. Major complications within 30 days. [ Time Frame: 30 days ]
    Composite of vascular mortality, nonfatal MI, nonfatal stroke, nonfatal PE, sepsis, and life-threatening bleeding.

Secondary Outcome Measures :
  1. Nonfatal myocardial infarction [ Time Frame: 30 days ]
  2. Nonfatal myocardial injury after noncardiac surgery [ Time Frame: 30 days ]
  3. Nonfatal pulmonary embolism [ Time Frame: 30 days ]
  4. Nonfatal infection [ Time Frame: 30 days ]
  5. Nonfatal bleeding [ Time Frame: 30 days ]
  6. Nonfatal stroke [ Time Frame: 30 days ]
  7. New congestive heart failure [ Time Frame: 30 days ]
  8. New atrial fibrillation [ Time Frame: 30 days ]
  9. Nonfatal cardiac arrest [ Time Frame: 30 days ]
  10. Deep vein thrombosis [ Time Frame: 30 days ]
  11. New acute renal failure requiring dialysis [ Time Frame: 30 days ]
  12. Cardiac catheterization [ Time Frame: 30 days ]
  13. PCI [ Time Frame: 30 days ]
  14. CABG [ Time Frame: 30 days ]
  15. CAM days 1-7 post-op [ Time Frame: 1-7 days post-op ]
  16. Implant failure or periprosthetic fracture [ Time Frame: 30 days ]
  17. Re-operation [ Time Frame: 30 days ]
  18. Length of hospital stay [ Time Frame: 30 days ]
  19. New nursing home residence [ Time Frame: 30 days ]
  20. First mobilization [ Time Frame: 30 days ]
  21. FIM (motor function) [ Time Frame: 30 days ]

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
Patients with hip fracture

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).

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 identifier (NCT number): NCT01984385

Canada, Ontario
Juravinski Hospital and Cancer Centre (HHS)
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
Population Health Research Institute
Principal Investigator: PJ Devereaux, PhD Population Health Research Institute

Responsible Party: P.J. Devereaux, MD, PhD, FRCP(C), Population Health Research Institute Identifier: NCT01984385     History of Changes
Other Study ID Numbers: HipVISION Pilot - 2013
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015

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