Hip FracturesHIPATTACKNCT01344343
HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial
A study testing Accelerated surgical hip fracture repair in people with Hip Fractures, run by Population Health Research Institute at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Accelerated surgical hip fracture repair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥ 45 years AND
- diagnosed during working hours on week days with a hip fracture requiring surgery
Who cannot join
- 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.
Show all 26Show fewer
- 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;
- hereditary or acquired coagulopathy that cannot be corrected within 2 hours to a INR < 1.5,
- thrombocytopenia (platelets < 75) of unknown origin that cannot be corrected within 2 hours or in case of known chronic thrombocytopenia platelets < 50;
- deep venous thrombosis in the last month requiring implantation of vena-cava filter;
- acute stroke within 7 days of fracture;
- subarachnoid hemorrhage within 1 month of fracture;
- impaired consciousness of unknown origin (Glasgow coma scale < 12);
- fractures acquired during a seizure in patients without a known history of epilepsy;
- hyponatremia (< 120 mmol/L) or hypernatremia (> 155 mmol/L) or hyponatremia < 125 mmol/L or hypernatremia >150 mmol/L associated with severe neurological symptoms (impaired consciousness to coma, seizures);
- hyperkalemia > 5.5 mmol/L with QRS-complex > 120 milliseconds (in patients without known previous QRS-complex > 120 ms) or hypokalemia < 2.8 mmol/L not amenable to correction within 2 hours;
- known pH < 7.15 not amenable to correction within 2 hours; or
- indication for acute dialysis.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
St. Joseph Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
India1 site
Sancheti Institute for Orthopaedics and Rehabilitation
Pune, Maharashtra, 411005
About this study
Official title: HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial - Feasibility Pilot
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).
Read the detailed description
Hip fractures have devastating consequences: the 30-day mortality rate for men is 9% and for women is 5%, and the risk of disability is substantial. Even among patients who are community-dwelling prior to their hip fracture, 11% are bed-ridden and 16% are in a long-term care facility after one year.
The trauma associated with a hip fracture results in pain, bleeding, and immobility. These factors initiate inflammatory, hypercoaguable, stress, and catabolic states that can cause medical complications, including death. Proposed mechanisms for increased mortality and morbidity associated with delayed surgery include 1) complications related to a protracted immobilization (e.g. venous thromboembolism, atelectasis and pneumonia, urinary tract infections, pressure ulcers, and muscle mass loss) and 2) increased cardiovascular events.
Delay in surgery may result in protracted immobility and the associated complications, as well as prolonged exposure to the hypercoagulable-inflammatory-sympathetic state which may increase cardiovascular events. Observational data suggests that these mechanisms are indeed important: delayed surgical repair is associated with increased mortality and morbidity after a hip fracture.
A systematic review and meta-analysis of observational studies addressed the impact of timing of surgery on the outcome after hip fracture. Five studies reported adjusted measures for mortality. The pooled estimate, based on 721 deaths in 4,208 patients, suggested that early surgical treatment (i.e. within the cut-off of the individual studies) of hip fractures was associated with a significant reduction in mortality (adjusted risk ratio [RR] 0.81, 95% confidence interval [CI] 0.68-0.96).
It is possible that these observational data substantially underestimates the real potential of early surgery. The reason is that the "early surgery" in these studies occurred within 24, 48 or 72 hours. If surgery could be uniformly undertaken within 6 hours, given the potential benefits of earlier mobilization and minimization of the period of the inflammatory hypercoagulable state, the benefits might be substantially greater. The substantial impact of treatment of acute myocardial infarction (MI) or stroke within hours adds credence to this possibility.
Despite the evidence, and the possibility that a larger effect might result from even earlier surgery, current data supports only weak inferences. The evidence relies on observational data and is therefore susceptible to residual confounding. The strength of inference from current evidence does not lay a sufficient solid base to justify the substantial system modification required to facilitate accelerated surgical access for all hip fracture patients.
The main factors that cause surgical delay after a hip fracture are: 1) the patient presents with comorbidities and surgery is deferred for preoperative diagnostics, risk stratification, and medical optimization ("medical clearance") and 2) surgical operating room and staff resources are not available because hip fractures have low priority in urgent surgery lists ("queuing"). Both medical clearance and queuing are modifiable issues - addressing these obstacles has the potential to substantially reduce surgical wait times.
Our ultimate goal is to undertake a large multicentre randomized controlled trial (RCT) of accelerated surgical care (i.e., goal of surgery within 6 hours of diagnosis) versus usual timing of surgery among elderly adults diagnosed with a hip fracture. This protocol is for a pilot RCT that will inform the feasibility of undertaking a large RCT.
- Conditions
- Hip Fractures
- Being tested
- Accelerated surgical hip fracture repair
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated surgical hip fracture repairOther
Accelerated hip fracture surgery defined as arrival in the operation room within 6 hours of diagnosis of a hip fracture requiring surgery
| Study group | Role | What they receive |
|---|---|---|
| Accelerated hip fracture surgery | Experimental | Arrival in the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair Receives: Other: Accelerated surgical hip fracture repair |
| Standard care | No intervention | Surgical hip fracture repair according to the standard timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (18)
All-cause mortality
Measured: 30 days
Length of hospital stay
Measured: 30 days
Length of intensive care unit stay
Measured: 30 days
Length of stay in rehabilitation facility
Measured: 30 days
New admission to a long-term care facility
Measured: 30 days
Functional Independence Measure (motor domain)
Measured: 30 days
Short form health survey (SF-36) (acute form)
Acute form = 1 week recall
Measured: 30 days
Delirium
Delirium, as defined by the Confusion Assessment Method
Measured: 7 days after randomization
Pre-operative Myocardial Infarction
Measured: 30 Days
Nonfatal Stroke
Measured: 30 Days
Nonfatal Pneumonia
Measured: 30 Days
Nonfatal Pulmonary Embolism
Measured: 30 Days
Sepsis
Measured: 30 Days
New Congestive Heart Failure
Measured: 30 Days
Nonfatal Cardiac Arrest
Measured: 30 Days
Nonfatal myocardial injury after non cardiac surgery (MINS)
Myocardial cell injury caused by ischemia, which occurs within 30 days after noncardiac surgery and has short-term prognostic relevance.
The diagnostic criteria for MINS is within the first 30-days after noncardiac surgery a troponin T value ≥0.03 ng/mL that is felt do to ischemia. MINS does not include perioperative myocardial injury that is due to pulmonary embolism, sepsis, cardioversion, a known troponin antibody or known chronically elevated troponin measurements, or another known nonischemic etiology.
Measured: 30 Days
Composite Endpoint
Composite Outcome of of all-cause mortality, nonfatal pre-operative myocardial infarction, nonfatal myocardial injury after noncardiac surgery (MINS), nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal life-threatening or major bleeding, and nonfatal stroke at 30 days.
Measured: 30 Days
Major or Life-threatening Bleeding
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, P.J. Devereaux, Population Health Research Institute
- Investigators
- Philip J Devereaux, MD, PhD, Principal investigator, Population Health Research Institute, McMaster UniversityMohit Bhandari, MD, MSc, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344343
- Sponsor's protocol ID
- HIPATTACK -6.0, 2012-09-24
- Acronym
- HIPATTACK
- Status last verified
- Nov 2012
- First submitted
- 27 Apr 2011
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20837683Hip 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.
PubMed 24246589
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial - Feasibility Pilot
- ClinicalTrials.gov ID
- NCT01344343
- Acronym / sponsor ID
- HIPATTACK / HIPATTACK -6.0, 2012-09-24
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- Jul 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Hip fractures have devastating consequences: the 30-day mortality rate for men is 9% and for women is 5%, and the risk of disability is substantial. Even among patients who are community-dwelling prior to their hip fracture, 11% are bed-ridden and 16% are in a long-term care facility after one year.
The trauma associated with a hip fracture results in pain, bleeding, and immobility. These factors initiate inflammatory, hypercoaguable, stress, and catabolic states that can cause medical complications, including death. Proposed mechanisms for increased mortality and morbidity associated with delayed surgery include 1) complications related to a protracted immobilization (e.g. venous thromboembolism, atelectasis and pneumonia, urinary tract infections, pressure ulcers, and muscle mass loss) and 2) increased cardiovascular events.
Delay in surgery may result in protracted immobility and the associated complications, as well as prolonged exposure to the hypercoagulable-inflammatory-sympathetic state which may increase cardiovascular events. Observational data suggests that these mechanisms are indeed important: delayed surgical repair is associated with increased mortality and morbidity after a hip fracture.
A systematic review and meta-analysis of observational studies addressed the impact of timing of surgery on the outcome after hip fracture. Five studies reported adjusted measures for mortality. The pooled estimate, based on 721 deaths in 4,208 patients, suggested that early surgical treatment (i.e. within the cut-off of the individual studies) of hip fractures was associated with a significant reduction in mortality (adjusted risk ratio [RR] 0.81, 95% confidence interval [CI] 0.68-0.96).
It is possible that these observational data substantially underestimates the real potential of early surgery. The reason is that the "early surgery" in these studies occurred within 24, 48 or 72 hours. If surgery could be uniformly undertaken within 6 hours, given the potential benefits of earlier mobilization and minimization of the period of the inflammatory hypercoagulable state, the benefits might be substantially greater. The substantial impact of treatment of acute myocardial infarction (MI) or stroke within hours adds credence to this possibility.
Despite the evidence, and the possibility that a larger effect might result from even earlier surgery, current data supports only weak inferences. The evidence relies on observational data and is therefore susceptible to residual confounding. The strength of inference from current evidence does not lay a sufficient solid base to justify the substantial system modification required to facilitate accelerated surgical access for all hip fracture patients.
The main factors that cause surgical delay after a hip fracture are: 1) the patient presents with comorbidities and surgery is deferred for preoperative diagnostics, risk stratification, and medical optimization ("medical clearance") and 2) surgical operating room and staff resources are not available because hip fractures have low priority in urgent surgery lists ("queuing"). Both medical clearance and queuing are modifiable issues - addressing these obstacles has the potential to substantially reduce surgical wait times.
Our ultimate goal is to undertake a large multicentre randomized controlled trial (RCT) of accelerated surgical care (i.e., goal of surgery within 6 hours of diagnosis) versus usual timing of surgery among elderly adults diagnosed with a hip fracture. This protocol is for a pilot RCT that will inform the feasibility of undertaking a large RCT.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated hip fracture surgery | Experimental | Other: Accelerated surgical hip fracture repairArrival in the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair |
| Standard care | No intervention | –Surgical hip fracture repair according to the standard timing |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged ≥ 45 years AND
- diagnosed during working hours on week days with a hip fracture requiring surgery
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated surgical hip fracture repairAccelerated hip fracture surgery defined as arrival in the operation room within 6 hours of diagnosis of a hip fracture requiring surgery | Other | Accelerated hip fracture surgery |
Primary outcome
Feasibility
Time frame: 18 months
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 secondary outcomes
All-cause mortality
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Length of intensive care unit stay
Time frame: 30 days
Length of stay in rehabilitation facility
Time frame: 30 days
New admission to a long-term care facility
Time frame: 30 days
Functional Independence Measure (motor domain)
Time frame: 30 days
Short form health survey (SF-36) (acute form)
Time frame: 30 days
Delirium
Time frame: 7 days after randomization
Pre-operative Myocardial Infarction
Time frame: 30 Days
Nonfatal Stroke
Time frame: 30 Days
Nonfatal Pneumonia
Time frame: 30 Days
Nonfatal Pulmonary Embolism
Time frame: 30 Days
Sepsis
Time frame: 30 Days
New Congestive Heart Failure
Time frame: 30 Days
Nonfatal Cardiac Arrest
Time frame: 30 Days
Nonfatal myocardial injury after non cardiac surgery (MINS)
Time frame: 30 Days
Composite Endpoint
Time frame: 30 Days
Major or Life-threatening Bleeding
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
- Background: PubMed 20837683Simunovic 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.
- Derived from this study: PubMed 24246589Hip 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip J Devereaux, MD, PhD principal investigator
Population Health Research Institute, McMaster University
Mohit Bhandari, MD, MSc principal investigator
Hamilton Health Sciences Corporation
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated surgical hip fracture repair in people with Hip Fractures, run by Population Health Research Institute at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01344343, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2012.