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

NCT01984385 | Completed

• 1 other identifier: HipVISION Pilot - 2013
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (2)

• Total and cause specific mortality in hip fracture patients at 30 days

  30 days

• Major complications within 30 days.

  Composite of vascular mortality, nonfatal MI, nonfatal stroke, nonfatal PE, sepsis, and life-threatening bleeding.

  30 days

Secondary Outcomes (21)

• Nonfatal myocardial infarction

  30 days

• Nonfatal myocardial injury after noncardiac surgery

  30 days

• Nonfatal pulmonary embolism

  30 days

• Nonfatal infection

  30 days

• Nonfatal bleeding

  30 days

Study Arms (1)

Patients with a hip fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hip fracture

You may qualify if:

• Patients aged ≥ 18 years with hip fractures (i.e. fractures involving the subcapital, femoral neck, or intertrochanteric regions), treated either operatively or non-operatively
• Mechanism of injury consistent with either:
• A fall from a standing height or;
• 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

You may not qualify if:

• Patients with fractures isolated to the proximal femoral shaft, with no involvement of the intertrochanteric, femoral neck, or subcapital region
• Patients with hip fractures resulting from high energy mechanisms, such as motor vehicle accidents or falls from a substantial height
• Patient who refuse 30-day or 6-month follow up
• 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).

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (1)

Juravinski Hospital and Cancer Centre (HHS)

Hamilton, Ontario, L8V 5C2, Canada

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• PJ Devereaux, PhD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCP(C)

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: December 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

CA (1)