Clinical trial NCT01984385: Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot Study
Official title: Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hip fracture

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.


Eligibility 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).

Primary outcomes:
measure: Total and cause specific mortality in hip fracture patients at 30 days
timeFrame: 30 days
measure: Major complications within 30 days.
timeFrame: 30 days
Secondary outcomes:
measure: Nonfatal myocardial infarction
timeFrame: 30 days
measure: Nonfatal myocardial injury after noncardiac surgery
timeFrame: 30 days
measure: Nonfatal pulmonary embolism
timeFrame: 30 days
measure: Nonfatal infection
timeFrame: 30 days
measure: Nonfatal bleeding
timeFrame: 30 days
measure: Nonfatal stroke
timeFrame: 30 days
measure: New congestive heart failure
timeFrame: 30 days
measure: New atrial fibrillation
timeFrame: 30 days
measure: Nonfatal cardiac arrest
timeFrame: 30 days
measure: Deep vein thrombosis
timeFrame: 30 days
measure: New acute renal failure requiring dialysis
timeFrame: 30 days
measure: Cardiac catheterization
timeFrame: 30 days
measure: PCI
timeFrame: 30 days
measure: CABG
timeFrame: 30 days
measure: CAM days 1-7 post-op
timeFrame: 1-7 days post-op
measure: Implant failure or periprosthetic fracture
timeFrame: 30 days
measure: Re-operation
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: New nursing home residence
timeFrame: 30 days
measure: First mobilization
timeFrame: 30 days
measure: FIM (motor function)
timeFrame: 30 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital and Cancer Centre (HHS)
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: PJ Devereaux, PhD
role: PRINCIPAL_INVESTIGATOR
References: