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Completed

NCT Number: NCT02027896

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

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).

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Accelerated medical clearance and surgery

Other

Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Health Sciences Corporation
  • Population Health Research Institute

Registry information

Acronym: HIP ATTACK

Important dates

Study start
2014
Primary completion
2019
Study completion
2022
First posted
Jan 6, 2014
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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