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HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial (HIP ATTACK)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by McMaster University ( Population Health Research Institute )
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
McMaster University ( Population Health Research Institute )
ClinicalTrials.gov Identifier:
NCT02027896
First received: January 2, 2014
Last updated: August 24, 2017
Last verified: August 2017
  Purpose
HIP ATTACK is an international randomized controlled trial of 1200 patients with a hip fracture that requires a surgical intervention. This trial will determine the effect of accelerated medical clearance and accelerated surgery compared to standard care on the 30-day risk of a major perioperative complication (i.e., a composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding).

Condition Intervention
Hip Fractures Other: Accelerated medical clearance and surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial

Resource links provided by NLM:


Further study details as provided by McMaster University ( Population Health Research Institute ):

Primary Outcome Measures:
  • Composite - major perioperative complication [ Time Frame: 30 days ]
    Composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding


Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 30 days and 1 year ]
    Death due to all causes

  • Vascular mortality [ Time Frame: 30 days and 1 year ]
    Death due to vascular cause

  • Non-vascular mortality [ Time Frame: 30 days and 1 year ]
    Death due to non-vascular cause

  • Myocardial infarction [ Time Frame: 30 days and 1 year ]
    Myocardial infarction

  • Cardiac revascularization procedure [ Time Frame: 30 days and 1 year ]
    i.e., percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] surgery

  • New congestive heart failure [ Time Frame: 30 days and 1 year ]
  • New clinically important atrial fibrillation [ Time Frame: 30 days ]
    New clinically important atrial fibrillation

  • Nonfatal cardiac arrest [ Time Frame: 30 days and 1 year ]
  • Stroke [ Time Frame: 30 days and 1 year ]
  • Peripheral arterial thrombosis [ Time Frame: 30 days and 1 year ]
  • Pulmonary embolism [ Time Frame: 30 days and 1 year ]
  • Deep venous thrombosis [ Time Frame: 30 days and 1 year ]
  • Pneumonia [ Time Frame: 30 days and 1 year ]
  • Sepsis [ Time Frame: 30 days and 1 year ]
  • Infection [ Time Frame: 30 days ]
  • Life-threatening bleeding [ Time Frame: 30 days ]
  • Major bleeding [ Time Frame: 30 days ]
  • New acute renal failure requiring dialysis [ Time Frame: 30 days and 1 year ]
  • Peri-prosthetic fracture [ Time Frame: 30 days and 1 year ]
  • Prosthetic hip dislocation [ Time Frame: 30 days and 1 year ]
  • Implant failure [ Time Frame: 30 days and 1 year ]
  • Hip re-operation [ Time Frame: 30 days and 1 year ]
  • Time to first mobilization [ Time Frame: 30 days ]
  • Length of hospital stay [ Time Frame: 30 days ]
  • Length of critical care stay [ Time Frame: 30 days ]
  • Length of rehabilitation stay [ Time Frame: 30 days ]
  • New residence in a nursing home [ Time Frame: 30 days and 1 year ]
  • Functional Independence Measure (FIM™) [ Time Frame: 30 days and 1 year ]
  • SF-36 score [ Time Frame: 30 days and 1 year ]
  • Delirium within 7 days of randomization [ Time Frame: 30 days ]
  • Hospital readmission [ Time Frame: 30 days and 1 year ]
  • New pressure ulcers [ Time Frame: 30 days ]
  • Incisional pain [ Time Frame: 30 days ]
  • Chronic incisional pain [ Time Frame: 1 year ]
  • Acute Kidney Injury [ Time Frame: 30 Day ]
  • Acute Kidney Injury [ Time Frame: 1 Year ]
  • Mortality and Institutionalization status of dependents [ Time Frame: 30 Days ]
  • Mortality and Institutionalization status of dependents [ Time Frame: 1 Year ]
  • Economic Analysis [ Time Frame: 30 Days and 1 Year ]
  • Health System Utilization, Long Term Follow up [ Time Frame: 2, 5, 10 Years ]

Estimated Enrollment: 1200
Study Start Date: March 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accelerated medical clearance and surgery
Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.
Other: Accelerated medical clearance and surgery
Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.
No Intervention: Standard surgical care
Surgical hip fracture repair according to the standard timing.

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥45 years; and
  • diagnosis of hip fracture during working hours with a low-energy mechanism (i.e., falling from standing height) requiring surgery.

Exclusion Criteria:

  • patients requiring emergent surgery or emergent interventions for another reason (e.g., subdural hematoma, abdominal pathology requiring urgent laparotomy, acute limb ischemia, other fractures or trauma requiring emergent surgery, necrotising fasciitis, coronary revascularization, pacemaker-implantation);
  • open hip fracture;
  • bilateral hip fractures;
  • peri-prosthetic fracture;
  • therapeutic anticoagulation not induced by a Vitamin K Antagonist, unfractionated heparin, (e.g., administration of therapeutic Low Molecular Weight Heparin (LMWH) (>6,000 u/24h) in the 24 hours prior to enrolment, or intake of any other non-reversible oral anticoagulant(s) for which there is no reversing agent available
  • patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT);
  • patients refusing participation; or
  • patients previously enrolled in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027896

Contacts
Contact: Jessica Vincent, MSc 905-527-4322 ext 40635 jessica.vincent@phri.ca

  Show 44 Study Locations
Sponsors and Collaborators
Population Health Research Institute
McMaster University
Investigators
Principal Investigator: Philip J Devereaux, MD, PhD McMaster University
Principal Investigator: Mohit Bhandari, MD, PhD McMaster University
  More Information

Additional Information:
Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02027896     History of Changes
Other Study ID Numbers: HIP ATTACK Trial v4.0
Study First Received: January 2, 2014
Last Updated: August 24, 2017

Keywords provided by McMaster University ( Population Health Research Institute ):
Perioperative outcomes

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

ClinicalTrials.gov processed this record on September 21, 2017