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

NCT01344343 | Completed

• 1 other identifier: HIPATTACK -6.0, 2012-09-24
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

Brief Summary

There is preliminary evidence that suggests early surgical treatment of a hip fracture may improve patients' outcomes. The investigators propose to do a pilot randomized controlled trial (RCT) to assess the feasibility of a large RCT comparing accelerated surgical repair (i.e. surgery within 6 hours of a hip fracture diagnosis) versus standard care (typically surgery after 36-48 hours).

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Feasibility defined as: * ability to recruit 60 patients in 18 months * ability to achieve arrival in the operating room within 6 hours of diagnosis in \>=80% of the patients randomized to accelerated surgery * ability to achieve accelerated surgery in a timely manner * ability to achieve medical clearance in a timely manner * resource requirements to achieve recruitment and follow up

  18 months

Secondary Outcomes (18)

• All-cause mortality

  30 days

• Length of hospital stay

  30 days

• Length of intensive care unit stay

  30 days

• Length of stay in rehabilitation facility

  30 days

• New admission to a long-term care facility

  30 days

Study Arms (2)

Accelerated hip fracture surgery

EXPERIMENTAL

Arrival in the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair

Other: Accelerated surgical hip fracture repair

Standard care

NO INTERVENTION

Surgical hip fracture repair according to the standard timing

Interventions

Accelerated surgical hip fracture repair OTHER

Accelerated hip fracture surgery defined as arrival in the operation room within 6 hours of diagnosis of a hip fracture requiring surgery

Accelerated hip fracture surgery

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥ 45 years AND
• diagnosed during working hours on week days with a hip fracture requiring surgery

You may not qualify if:

• We will exclude patients based on the following criteria:
• patients requiring urgent surgery or urgent interventions for another reason (e.g., subdural hematoma, abdominal pathology requiring urgent laparotomy, acute limb ischemia, other fractures or trauma requiring urgent surgery, or necrotising fascitis; PCI; pacemaker-implantation);
• open hip fracture;
• patients refusing participation;
• patients previously enrolled in the study;
• Therapeutic anticoagulation not induced by warfarin or intravenous heparin.
• Criteria in which the timeline of the surgery in the accelerated care group (after accelerated medical work-up) are at the discretion of the attending physicians.
• acute myocardial infarction associated with a mechanical complication (i.e., acute papillary muscle rupture, ventricular septal defect) or ST-elevation MI;
• cardiac arrest;
• cardiogenic shock, defined by systemic hypotension and symptoms of organ hypoperfusion (oliguria, change in mental status, cold extremities) that the treating physician believes is due to a low cardiac output state (measurement of cardiac index or pulmonary capillary wedge pressure is not required) or requiring inotropic drugs;
• frank pulmonary edema that cannot be corrected within 2 hours (i.e. after 2 hours the patient cannot maintain oxygen saturation ≥ 90% in supine position with nasal oxygen or 28% oxygen);
• respiratory failure requiring mechanical ventilation;
• known pulmonary artery hypertension (\> 80 mm Hg);
• home oxygen therapy with concomitant non-warfarin full dose anticoagulation or clopidogrel (because regional anesthesia is not possible);
• presumptive bacteremia on the basis of fever ≥ 39° Celsius or two of the following: a) Temperature \>38° Celsius or \<35° Celsius; b) WBC \>12 or \< 4 or \>10% immature bands; c) rigors; and d) hypotension with evidence of organ dysfunction;

Sponsors & Collaborators

• Population Health Research Institute: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (3)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joseph Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Sancheti Institute for Orthopaedics and Rehabilitation

Pune, Maharashtra, 411005, India

Location

Related Publications (2)

• Simunovic N, Devereaux PJ, Sprague S, Guyatt GH, Schemitsch E, Debeer J, Bhandari M. Effect of early surgery after hip fracture on mortality and complications: systematic review and meta-analysis. CMAJ. 2010 Oct 19;182(15):1609-16. doi: 10.1503/cmaj.092220. Epub 2010 Sep 13.

  PMID: 20837683 BACKGROUND

• Hip Fracture Accelerated Surgical Treatment and Care Track (HIP ATTACK) Investigators. Accelerated care versus standard care among patients with hip fracture: the HIP ATTACK pilot trial. CMAJ. 2014 Jan 7;186(1):E52-60. doi: 10.1503/cmaj.130901. Epub 2013 Nov 18.

  PMID: 24246589 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Philip J Devereaux, MD, PhD

  Population Health Research Institute, McMaster University

  PRINCIPAL INVESTIGATOR

• Mohit Bhandari, MD, MSc

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 29, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 6, 2012

Record last verified: 2012-11

Locations

CA (2); IN (1)