HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

Hip Fractures Clinical Trial

— HIP ATTACK-2  

Official title:

HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 (HIP ATTACK-2) Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743765
• Other study ID #: v1.0_20210121
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: July 15, 2025

Study information

• Verified date: April 2024
• Source: Population Health Research Institute
• Contact: Valerie Harvey
• Phone: 905-297-3479
• Email: valerie.harvey[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: July 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. age =45 years;

2. diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery;

3. troponin elevation on hospital arrival (at least one troponin level from hip fracture occurrence to randomization above the upper limit of normal); and

4. written informed consent.

Exclusion Criteria:

1. taking a therapeutic dose of an anticoagulant for which no reversing agent is available;

2. patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT);

3. patients with peri-prosthetic fracture, open fracture or bilateral fractures;

4. patients requiring an emergency surgery for another reason (e.g., subdural hematoma);

5. patients with acute myocardial infarction with a mechanical complication (i.e., acute papillary muscle rupture, ventricular septal defect), ST elevation myocardial infarction, or cardiogenic shock;

6. patients refusing consent; or

7. patients previously enrolled in HIP ATTACK-2.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Myocardial Injury

Intervention

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.

Locations

Country	Name	City	State
Australia	The John Hunter Hospital	New Lambton Heights	New South Wales
Belgium	Cliniques Universitaires Saint Luc - University Catholic of Louvain	Woluwe-Saint-Lambert	Brussels
Brazil	University of São Paulo	São Paulo	SP
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Victoria Hospital	London	Ontario
Canada	Markham Stouffville Hospital	Markham	Ontario
Canada	Ottawa General Hospital	Ottawa	Ontario
Chile	Clinica Santa Maria	Santiago
Chile	Pontifica Universidad Catolica de Chile	Santiago	RM
Finland	South Karelia Central Hospital	Lappeenranta
Finland	Tampere University Hospital	Tampere
Hong Kong	Queen Mary Hospital	Hong Kong
India	Bangalore Baptist Hospital	Bangalore	Karnataka
Italy	Ospedale Galeazzi SpA	Milan
Italy	Ospedale San Raffaele S.r.l.	Milan
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Mexico	Christus Muguerza del Parque	Chihuahua
Mexico	Cruz Verde Guadalajara	Guadalajara	Jalisco
Nepal	B and B Hospital	Lalitpur	Bagmati
Netherlands	Deventer Hospital	Deventer	Overijssel
Pakistan	Maroof International Hospital	Islamabad	ICT
Pakistan	Shifa International Hospitals Ltd.	Islamabad	ICT
Pakistan	Aga Khan University	Karachi	Sindh
Pakistan	Indus Hospital & Health Network	Karachi	Sind
Pakistan	Ghurki Trust Teaching Hospital	Lahore	Punjab
Pakistan	Hayat Abad Medical Complex	Peshawar	KPK
Pakistan	Combined Military Hospital	Rawalpindi	Punjab
Poland	SPZOZ Myslenice	Myslenice	Malopolska
Saudi Arabia	King Faisal Specialist Hospital	Riyadh
South Africa	Groote Schuur Hospital	Cape Town	Western Cape
South Africa	Stellenbosch University - Tygerberg Hospital	Cape Town	Western Cape
Spain	Hospital Clinic of Barcelona	Barcelona
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitari Sagrat Cor	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Costa del Sol	Marbella	Malaga
Spain	Hospital Universitari Parc Tauli	Sabadell	Barcelona
Spain	Hospital Sant Camil	Sant Pere De Ribes	Barcelona
Spain	Hospital Universitario Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital Clinico Universitario de Vallad	Valladolid
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Maryland	Baltimore	Maryland
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Finland,  Hong Kong,  India,  Italy,  Malaysia,  Mexico,  Nepal,  Netherlands,  Pakistan,  Poland,  Saudi Arabia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New clinically important atrial fibrillation	Documentation of atrial fibrillation or atrial flutter of any duration on an ECG or rhythm strip and results in angina, congestive heart failure, symptomatic hypotension, or requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion.	Within 90 days post randomization
Other	Cardiac revascularization procedure	Revascularization procedures including coronary artery bypass graft or percutaneous coronary intervention surgery.	Within 90 days post randomization
Other	Venous thromboembolism	Venous pulmonary embolism or deep venous thrombosis	Within 90 days post randomization
Other	Pulmonary embolism	The diagnosis of PE requires any one of the following: A high probability ventilation/perfusion lung scan,; An intraluminal filling defect of a segmental or larger artery on a helical CT scan,; An intraluminal filling defect on pulmonary angiography, or; A positive diagnostic test for DVT (e.g., positive compression ultrasound) and 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
Other	Proximal deep venous thrombosis	The diagnosis of proximal DVT requires: Thrombosis involving the popliteal vein or more proximal veins for leg DVT and axillary or more proximal veins for arm DVT, AND; Evidence of vein thrombosis by any one of the following: 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
Other	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
Other	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 due to infection. The qSOFA includes the following items and scoring system: Altered mental status (1 point),; Systolic blood pressure (SBP)of 100 mm Hg or less (1 point), and; Respiratory rate (RR) of 22 breaths/min or more (1 point).	Within 90 days post randomization
Other	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
Other	Bleeding	Life threatening, major or critical organ bleeding	Within 90 days post randomization
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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 surgery).	Within 90 days post randomization
Other	Hospital re-admission	Hospital re-admission following discharge from index hospitalization	Within 90 days post randomization
Other	Length of critical care stay	Length of critical care stay	Within 90 days post randomization
Other	Length of rehabilitation stay	Length of rehabilitation stay	Within 90 days post randomization
Other	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
Primary	All cause mortality	Death due to all causes	Within 90 days post randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	Nonvascular mortality	Any death due to a clearly documented non-vascular cause.	Within 90 days post randomization
Secondary	Myocardial Infarction	Diagnosis of MI according to 4th universal definition of myocardial infarction	Within 90 days post randomization
Secondary	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: radiographic findings (i.e., vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema) OR; heart failure treatment implemented with diuretics with documented clinical improvement.	Within 90 days post randomization
Secondary	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
Secondary	Time from randomization to hospital discharge	Length of hospital stay from randomization to hospital discharge	Within 90 days post randomization
Secondary	Delirium	Patient meets the criteria for delirium on any in-person 3D-CAM administered; OR; Positive history of delirium in the 7 days after randomization based on the review of hospital health records.	Within 7 days and 90 days post randomization
Secondary	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