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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated medical clearance and surgery | Experimental | Accelerated medical clearance and targeted arrival to the operating room within 6 hours of eligibility criteria met. |
|
| Standard surgical care | No Intervention | Hip fracture repair and surgical care according to treating institution guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated medical clearance and surgery | Other | Rapid medical clearance with targeted arrival to the operating room within 6 hours of eligibility criteria criteria met. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Death due to all causes | Within 90 days post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to independently walk 3 meters | Ability to independently walk 3 meters (10 feet) or across a room without human assistance. Patients who require a cane or walker, but not human assistance, will be classified as able to walk independently. Patients who require assistance to get out of a chair, but can walk independently once they get up, will be classified as able to walk independently. | Within 90 days post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| New clinically important atrial fibrillation or flutter | Documentation of atrial fibrillation or atrial flutter of any duration on an ECG, telemetry tracing, or rhythm strip and results in angina, congestive heart failure, symptomatic hypotension, or is followed by initiation or a dose increase of a rate controlling drug, antiarrhythmic drug, or electrical cardioversion. | Within 90 days post randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valerie Harvey | Contact | 905-297-3479 | 40793 | valerie.harvey@phri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Flavia Borges, M.D | Population Health Research Institute | Principal Investigator |
| Gerard Slobogean, M.D | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler Regional Medical Center | Recruiting | Chandler | Arizona | 85224 | United States |
The Population Health Research Institute (PHRI) is the sponsor of this trial. The PHRI believes the dissemination of clinical research results is vital and sharing of data is important. PHRI prioritizes access to data analyses to researchers who have worked on the trial for a significant duration, have played substantial roles, and have participated in raising the funds to conduct the trial. PHRI balances the length of the research study, and the intellectual and financial investments that made it possible with the need to allow wider access to the data collected. Data will be disclosed only upon request and approval of the proposed use of the data by a Review Committee.
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| Composite of major complications | Composite includes vascular and nonvascular mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke. | Within 90 days post randomization |
| Vascular mortality | Any death with a vascular cause and includes those deaths following a myocardial infarction, sudden cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery), heart failure, pulmonary embolus, cardiovascular hemorrhage, or deaths due to an unknown cause | Within 90 days post randomization |
| Nonvascular mortality | Any death due to a clearly documented non-vascular cause. | Within 90 days post randomization |
| Myocardial Infarction | Diagnosis of MI according to 4th universal definition of myocardial infarction | Within 90 days post randomization |
| Acute Congestive Heart Failure | at least one clinical sign(s) or symptom(s) (e.g elevated jugular venous pressure, respiratory rales/crackles, crepitations, hypoxia, tachypnea or presence of S3) with at least one of the following:
| Within 90 days post randomization |
| Stroke | Either - 1. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting more than 24 hours or leading to death; or 2. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting less 24 hours with a positive neuroimaging consistent with a stroke | Within 90 days post randomization |
| Time from randomization to hospital discharge | Length of hospital stay from randomization to hospital discharge | Within 90 days post randomization |
| Delirium |
| Within 7 days and 90 days post randomization |
| Moderate to severe pain | Moderate to severe pain is defined as any pain score ≥3 on 10 points scale. | Within 7 days and 90 days post randomization |
| Cardiac revascularization procedure | Revascularization procedures including coronary artery bypass graft or percutaneous coronary intervention surgery. | Within 90 days post randomization |
| Venous thromboembolism | Venous pulmonary embolism or deep venous thrombosis | Within 90 days post randomization |
| Pulmonary embolism | The diagnosis of PE requires any one of the following:
A. Non-diagnostic (i.e., low or intermediate probability) ventilation/perfusion lung scan B. Non-diagnostic (i.e., subsegmental defects or technically inadequate study) helical CT scan. | Within 90 days post randomization |
| Proximal deep venous thrombosis | The diagnosis of proximal DVT requires:
1. A persistent intraluminal filling defect on contrast venography, 2. Noncompressibility of one or more venous segments on B mode compression ultrasonography, or 3. A clearly defined intraluminal filling defect on contrast enhanced computed tomography. | Within 90 days post randomization |
| Infection | Pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms. | Within 90 days post randomization |
| Sepsis | Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria,20 sepsis will require a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points or patients requiring vasopressors/inotropes due to infection. The qSOFA includes the following items and scoring system:
| Within 90 days post randomization |
| Pneumonia | Acute infection of the pulmonary parenchyma that is associated with at least one sign or symptom of lower respiratory acute infection (e.g., cough, pleuritic chest pain) or acute systemic illness (e.g., fever, chills, confusion, hypoxemia); accompanied by the presence of an acute infiltrate/consolidation on a chest radiograph or auscultatory findings consistent with pneumonia (such as crackles and/or localized rales) for which there is no other explanation. | Within 90 days post randomization |
| Bleeding | Life threatening, major or critical organ bleeding | Within 90 days post randomization |
| Hip reoperation | Any second surgical procedure undertaken on the fractured hip being followed in the study, for any reason (e.g. infection, implant failure, periprosthetic fracture, wound dehiscence, etc.), after it has been initially repaired and the patient has left the operating room. | Within 90 days post randomization |
| Prosthetic hip dislocation | Any acute dislocation of a prosthetic femoral head from within its intended concentric location within the acetabulum. The acetabulum may or may not be resurfaced/replaced. | Within 90 days post randomization |
| Implant failure | Any mechanical issue related to the integrity of any component of the hip implant which requires a surgical procedure to correct. This includes: loss of implant fixation to bone (either with or without associated periprosthetic fracture); or broken, disassociated, or dislocated implant components. | Within 90 days post randomization |
| Peri-prosthetic fracture | Fracture through any part of either the femur and/or acetabulum to which a hip implant used for hip repair/reconstruction was fixed. | Within 90 days post randomization |
| Acute kidney injury | An increase in the serum creatinine concentration from the pre-randomization value of ≥26.5 μmol/L (≥0.3 mg/dL) within 48 hours after randomization, or an increase of ≥50% within 7 days after randomization. | Within 90 days post randomization |
| Acute renal failure resulting in dialysis | New requirement for dialysis (i.e., use of hemodialysis machine or peritoneal dialysis apparatus in patients without a requirement for dialysis prior to randomization). | Within 90 days post randomization |
| Hospital re-admission | Hospital re-admission following discharge from index hospitalization | Within 90 days post randomization |
| Length of critical care stay | Length of critical care stay | Within 90 days post randomization |
| Length of rehabilitation stay | Length of rehabilitation stay | Within 90 days post randomization |
| Days alive at home | Days alive at home are the number of days patients spend at their usual residence without, during that day, being admitted to a hospital or visiting an emergency department or urgent-care centre. Patients lose days alive at home if 1. patients go to an emergency department or urgent-care centre; 2. they become inpatients at a hospital or rehabilitation or convalescence-care facility; or 3. they die. | Within 90 days post randomization |
| Robert Feibel, M.D |
| The Ottawa Hospital |
| Principal Investigator |
| PJ Devereaux, M.D | Population Health Research Institute | Study Chair |
| The Regents of the University of California | Recruiting | Davis | California | 95618 | United States |
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| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06520 | United States |
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| Emory University at Grady Memorial Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
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| University of Maryland | Recruiting | Baltimore | Maryland | 20742 | United States |
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| Sinai Hospital of Baltimore | Recruiting | Baltimore | Maryland | 21215 | United States |
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| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
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| Lahey Hospital and Medical Center | Recruiting | Burlington | Massachusetts | 01805 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Bryan Medical Center | Recruiting | Lincoln | Nebraska | 68506 | United States |
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| University Medical Center of Southern Nevada | Recruiting | Las Vegas | Nevada | 89102 | United States |
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| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
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| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| St. Luke's University Health Network | Recruiting | Bethlehem | Pennsylvania | 18015 | United States |
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| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| University of Wisconsin | Recruiting | Madison | Wisconsin | 53715 | United States |
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| The John Hunter Hospital | Recruiting | New Lambton Heights | New South Wales | 2305 | Australia |
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| Cliniques Universitaires Saint Luc - University Catholic of Louvain | Recruiting | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
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| University of São Paulo | Recruiting | São Paulo | São Paulo | 05403010 | Brazil |
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| University of Alberta Hospital | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
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| St. Joseph's Healthcare Hamilton | Recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
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| Juravinski Hospital | Recruiting | Hamilton | Ontario | L8V 1C3 | Canada |
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| Victoria Hospital | Recruiting | London | Ontario | N6A 5W9 | Canada |
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| Markham Stouffville Hospital | Recruiting | Markham | Ontario | L3P 7P3 | Canada |
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| Ottawa General Hospital | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| CISSS de Laval | Recruiting | Laval | Quebec | H7M 3L9 | Canada |
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| Pontifica Universidad Catolica de Chile | Recruiting | Santiago | RM | 83300024 | Chile |
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| Clinica Santa Maria | Recruiting | Santiago | 7520378 | Chile |
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| South Karelia Central Hospital | Recruiting | Lappeenranta | 53130 | Finland |
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| Tampere University Hospital | Recruiting | Tampere | 33521 | Finland |
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| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
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| Bangalore Baptist Hospital | Recruiting | Bangalore | Karnataka | 560024 | India |
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| Government TD Medical College | Recruiting | Alappuzha | Kerala | 688005 | India |
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| Government Medical College | Recruiting | Trivandrum | Kerala | 695011 | India |
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| All India Institute of Medical Sciences (AIIMS) | Recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
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| JIPMER | Recruiting | Puducherry | Puducherry | 605006 | India |
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| Hospital of Perugia | Recruiting | Perugia | Umbria | 06129 | Italy |
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| Galliera Hospital | Recruiting | Genova | 16128 | Italy |
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| Ospedale San Raffaele S.r.l. | Recruiting | Milan | 20132 | Italy |
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| Ospedale Galeazzi SpA | Recruiting | Milan | 20157 | Italy |
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| University of Malaya Medical Centre | Recruiting | Kuala Lumpur | 59100 | Malaysia |
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| Christus Muguerza del Parque | Recruiting | Chihuahua City | Chihuahua | 31000 | Mexico |
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| Cruz Verde Guadalajara | Recruiting | Guadalajara | Jalisco | 44410 | Mexico |
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| B and B Hospital | Recruiting | Lalitpur | Bagmati | 44700 | Nepal |
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| Deventer Hospital | Recruiting | Deventer | Overijssel | 7416 SE | Netherlands |
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| Stichting OLVG | Recruiting | Amsterdam | Netherlands |
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| Maroof International Hospital | Recruiting | Islamabad | ICT | 44000 | Pakistan |
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| Shifa International Hospitals Ltd. | Recruiting | Islamabad | ICT | 44000 | Pakistan |
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| Hayat Abad Medical Complex | Recruiting | Peshawar | KPK | 25000 | Pakistan |
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| Ghurki Trust Teaching Hospital | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
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| Combined Military Hospital | Recruiting | Rawalpindi | Punjab Province | 46000 | Pakistan |
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| Aga Khan University | Recruiting | Karachi | Sindh | 74800 | Pakistan |
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| Indus Hospital & Health Network | Recruiting | Karachi | Sindh | Pakistan |
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| SPZOZ Myslenice | Recruiting | Myślenice | Malopolska | 32-400 | Poland |
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| King Faisal Specialist Hospital | Recruiting | Riyadh | Riyadh Region | 11211 | Saudi Arabia |
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| Stellenbosch University - Tygerberg Hospital | Recruiting | Cape Town | Western Cape | 7505 | South Africa |
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| Groote Schuur Hospital | Recruiting | Cape Town | Western Cape | 7925 | South Africa |
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| Hospital Universitari Sagrat Cor | Recruiting | Barcelona | Barcelona | 08029 | Spain |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
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| Hospital Clinic of Barcelona | Recruiting | Barcelona | Barcelona | 08036 | Spain |
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| Hospital de la Santa Creu I Sant Pau | Recruiting | Barcelona | Barcelona | 08041 | Spain |
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| Hospital Universitari Parc Tauli | Recruiting | Sabadell | Barcelona | 08208 | Spain |
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| Hospital Sant Camil | Recruiting | Sant Pere de Ribes | Barcelona | 08810 | Spain |
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| Hospital Universitario Mutua de Terrassa | Recruiting | Terrassa | Barcelona | 08221 | Spain |
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| Hospital Costa del Sol | Recruiting | Marbella | Malaga | 29603 | Spain |
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| Hospital Clinico Universitario de Vallad | Recruiting | Valladolid | Valladolid | 47007 | Spain |
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| Parc Sanitari Sant Joan de Déu | Recruiting | Barcelona | 08830 | Spain |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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