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

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ClinicalTrials.gov Identifier: NCT02027896
Recruitment Status : Recruiting
First Posted : January 6, 2014
Last Update Posted : May 31, 2018
Sponsor:
Collaborators:
Population Health Research Institute
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University

Brief Summary:
HIP ATTACK is an international randomized controlled trial of 3000 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 90-day risk of mortality and 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 or disease Intervention/treatment Phase
Hip Fractures Other: Accelerated medical clearance and surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
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
Study Start Date : March 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Composite - major perioperative complication [ Time Frame: 90 days ]
    Composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding

  2. Mortality [ Time Frame: 90 days ]
    All-cause mortality


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 90 days and 1 year ]
    Death due to all causes

  2. Vascular mortality [ Time Frame: 90 days and 1 year ]
    Death due to vascular cause

  3. Non-vascular mortality [ Time Frame: 90 days and 1 year ]
    Death due to non-vascular cause

  4. Myocardial infarction [ Time Frame: 90 days and 1 year ]
    Myocardial infarction

  5. Cardiac revascularization procedure [ Time Frame: 90 days and 1 year ]
    i.e., percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] surgery

  6. New congestive heart failure [ Time Frame: 90 days and 1 year ]
    New congestive heart failure

  7. New clinically important atrial fibrillation [ Time Frame: 90 days ]
    New clinically important atrial fibrillation

  8. Nonfatal cardiac arrest [ Time Frame: 30 days and 1 year ]
    Nonfatal cardiac arrest

  9. Stroke [ Time Frame: 90 days and 1 year ]
    Stroke

  10. Peripheral arterial thrombosis [ Time Frame: 90 days and 1 year ]
    Peripheral arterial thrombosis

  11. Pulmonary embolism [ Time Frame: 90 days and 1 year ]
    Pulmonary embolism

  12. Deep venous thrombosis [ Time Frame: 90 days and 1 year ]
    Deep venous thrombosis

  13. Pneumonia [ Time Frame: 90 days and 1 year ]
    Pneumonia

  14. Sepsis [ Time Frame: 90 days and 1 year ]
    Sepsis

  15. Infection [ Time Frame: 90 days ]
    Infection

  16. Life-threatening bleeding [ Time Frame: 90 days ]
    Life-threatening bleeding

  17. Major bleeding [ Time Frame: 90 days ]
    Major bleeding

  18. New acute renal failure requiring dialysis [ Time Frame: 90 days and 1 year ]
    New acute renal failure requiring dialysis

  19. Peri-prosthetic fracture [ Time Frame: 90 days and 1 year ]
    Peri-prosthetic fracture

  20. Prosthetic hip dislocation [ Time Frame: 90 days and 1 year ]
    Prosthetic hip dislocation

  21. Implant failure [ Time Frame: 90 days and 1 year ]
    Implant failure

  22. Hip re-operation [ Time Frame: 30 days and 1 year ]
    Hip re-operation

  23. Time to first mobilization [ Time Frame: 90 days ]
    Time to first mobilization

  24. Length of hospital stay [ Time Frame: 90 days ]
    Length of hospital stay

  25. Length of critical care stay [ Time Frame: 90 days ]
    Length of critical care stay

  26. Length of rehabilitation stay [ Time Frame: 90 days ]
    Length of rehabilitation stay

  27. New residence in a nursing home [ Time Frame: 90 days and 1 year ]
    New residence in a nursing home

  28. Functional Independence Measure (FIM™) [ Time Frame: 30 days and 1 year ]
    Functional Independence Measure (FIM™)

  29. SF-36 score [ Time Frame: 30 days and 1 year ]
    SF-36 score

  30. Delirium within 7 days of randomization [ Time Frame: 7 days ]
    Delirium within 7 days of randomization

  31. Hospital readmission [ Time Frame: 90 days and 1 year ]
    Hospital readmission

  32. New pressure ulcers [ Time Frame: 90 days ]
    New pressure ulcers

  33. Incisional pain [ Time Frame: 30 days ]
    Incisional pain

  34. Chronic incisional pain [ Time Frame: 1 year ]
    Chronic incisional pain

  35. Acute Kidney Injury [ Time Frame: 90 Day ]
    Acute Kidney Injury

  36. Acute Kidney Injury [ Time Frame: 1 Year ]
    Acute Kidney Injury

  37. Mortality and Institutionalization status of dependents [ Time Frame: 30 Days ]
    Mortality and Institutionalization status of dependents

  38. Mortality and Institutionalization status of dependents [ Time Frame: 1 Year ]
    Mortality and Institutionalization status of dependents

  39. Economic Analysis [ Time Frame: 90 Days and 1 Year ]
    Economic Analysis

  40. Health System Utilization, Long Term Follow up [ Time Frame: 2, 5, 10 Years ]
    Health System Utilization, Long Term Follow up



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
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.

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 ClinicalTrials.gov identifier (NCT number): NCT02027896


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

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

Additional Information:
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02027896     History of Changes
Other Study ID Numbers: HIP ATTACK Trial v4.0
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Keywords provided by McMaster University:
Perioperative outcomes

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