HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

Not Applicable

Recruiting

• Conditions: Hip Fractures; Myocardial Injury
• Interventions: Other: Accelerated medical clearance and surgery

• Registration Number: NCT04743765
• Lead Sponsor: Population Health Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-08
• Study Start: 2021-11-22
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-10
• Primary Completion: 2027-02-28
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. age ≥45 years;
2. diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery;
3. troponin elevation ( at least one troponin measurement above the upper limit of normal occurring from the time of hip fracture to the time of randomization); and
4. informed consent.

Exclusion Criteria

1. taking a therapeutic dose of an anticoagulant for which no reversing agent is available and the anesthesiologist or surgeon believe surgery within 6 hours of eligibility criteria met would not be safe;
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 deemed to be clinically unstable, 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerated medical clearance and surgery	Accelerated medical clearance and surgery	Accelerated medical clearance and targeted arrival to the operating room within 6 hours of eligibility criteria met.

Primary Outcome Measures

Name	Time	Method
All cause mortality	Within 90 days post randomization	Death due to all causes

Secondary Outcome Measures

Name	Time	Method
Delirium	Within 7 days and 90 days post randomization	1. Patient meets the criteria for delirium on any in-person 3D-CAM or CAM administered; OR; 2. Positive history of delirium in the 7 days after randomization based on the review of hospital health records.
Myocardial Infarction	Within 90 days post randomization	Diagnosis of MI according to 4th universal definition of myocardial infarction
Ability to independently walk 3 meters	Within 90 days post randomization	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.
Composite of major complications	Within 90 days post randomization	Composite includes vascular and nonvascular mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke.
Vascular mortality	Within 90 days post randomization	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
Stroke	Within 90 days post randomization	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
Time from randomization to hospital discharge	Within 90 days post randomization	Length of hospital stay from randomization to hospital discharge
Nonvascular mortality	Within 90 days post randomization	Any death due to a clearly documented non-vascular cause.
Acute Congestive Heart Failure	Within 90 days post randomization	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: 1. radiographic findings (i.e., vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema) or point of care ultrasound findings (i.e., bilateral B-lines, bilateral pleural effusion, elevated jugular venous pressure, dilated inferior vena cava with respiratory variation less than 50%) OR; 2. heart failure treatment implemented with diuretics with documented clinical improvement.
Moderate to severe pain	Within 7 days and 90 days post randomization	Moderate to severe pain is defined as any pain score ≥3 on 10 points scale.

Trial Locations

Locations (66)

The Regents of the University of California; 🇺🇸 Davis, California, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Bryan Medical Center; 🇺🇸 Lincoln, Nebraska, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

St. Luke's University Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

The John Hunter Hospital; 🇦🇺 New Lambton Heights, New South Wales, Australia

Cliniques Universitaires Saint Luc - University Catholic of Louvain; 🇧🇪 Woluwe-Saint-Lambert, Brussels, Belgium

University of São Paulo; 🇧🇷 São Paulo, SP, Brazil

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada

Juravinski Hospital; 🇨🇦 Hamilton, Ontario, Canada

Victoria Hospital; 🇨🇦 London, Ontario, Canada

Markham Stouffville Hospital; 🇨🇦 Markham, Ontario, Canada

Ottawa General Hospital; 🇨🇦 Ottawa, Ontario, Canada

CISSS de Laval; 🇨🇦 Laval, Quebec, Canada

Pontifica Universidad Catolica de Chile; 🇨🇱 Santiago, RM, Chile

Clinica Santa Maria; 🇨🇱 Santiago, Chile

South Karelia Central Hospital; 🇫🇮 Lappeenranta, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

All India Institute of Medical Sciences (AIIMS); 🇮🇳 New Delhi, Delhi, India

Bangalore Baptist Hospital; 🇮🇳 Bangalore, Karnataka, India

Government TD Medical College; 🇮🇳 Alappuzha, Kerala, India

Government Medical College; 🇮🇳 Trivandrum, Kerala, India

JIPMER; 🇮🇳 Pondicherry, India

Hospital of Perugia; 🇮🇹 Perugia, Umbria, Italy

Galliera Hospital; 🇮🇹 Genova, Italy

Ospedale San Raffaele S.r.l.; 🇮🇹 Milan, Italy

Ospedale Galeazzi SpA; 🇮🇹 Milan, Italy

University of Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

Cruz Verde Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico

Christus Muguerza del Parque; 🇲🇽 Chihuahua, Mexico

B and B Hospital; 🇳🇵 Lalitpur, Bagmati, Nepal

Deventer Hospital; 🇳🇱 Deventer, Overijssel, Netherlands

Stichting OLVG; 🇳🇱 Amsterdam, Netherlands

Maroof International Hospital; 🇵🇰 Islamabad, ICT, Pakistan

Shifa International Hospitals Ltd.; 🇵🇰 Islamabad, ICT, Pakistan

Hayat Abad Medical Complex; 🇵🇰 Peshawar, KPK, Pakistan

Ghurki Trust Teaching Hospital; 🇵🇰 Lahore, Punjab, Pakistan

Combined Military Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan

Indus Hospital & Health Network; 🇵🇰 Karachi, Sind, Pakistan

SPZOZ Myslenice; 🇵🇱 Myslenice, Malopolska, Poland

King Faisal Specialist Hospital; 🇸🇦 Riyadh, Saudi Arabia

Stellenbosch University - Tygerberg Hospital; 🇿🇦 Cape Town, Western Cape, South Africa

Groote Schuur Hospital; 🇿🇦 Cape Town, Western Cape, South Africa

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 Costa del Sol; 🇪🇸 Marbella, Malaga, Spain

Hospital Universitari Sagrat Cor; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Parc Sanitari Sant Joan de Déu; 🇪🇸 Barcelona, Spain

Hospital Clinico Universitario de Vallad; 🇪🇸 Valladolid, Spain