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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04743765




Registration number
NCT04743765
Ethics application status
Date submitted
3/02/2021
Date registered
8/02/2021

Titles & IDs
Public title
HIP Fracture Accelerated Surgical TreaTment and Care TracK 2 Trial
Scientific title
HIP Fracture Accelerated Surgical TreaTment and Care TracK 2 (HIP ATTACK-2) Trial
Secondary ID [1] 0 0
v1.0_20210121
Universal Trial Number (UTN)
Trial acronym
HIP ATTACK-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Fractures 0 0
Myocardial Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Accelerated medical clearance and surgery

Experimental: Accelerated medical clearance and surgery - Accelerated medical clearance and targeted arrival to the operating room within 6 hours of eligibility criteria met.

No intervention: Standard surgical care - Hip fracture repair and surgical care according to treating institution guidelines.


Other interventions: Accelerated medical clearance and surgery
Rapid medical clearance with targeted arrival to the operating room within 6 hours of eligibility criteria criteria met.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All cause mortality
Timepoint [1] 0 0
Within 90 days post randomization
Secondary outcome [1] 0 0
Ability to independently walk 3 meters
Timepoint [1] 0 0
Within 90 days post randomization
Secondary outcome [2] 0 0
Composite of major complications
Timepoint [2] 0 0
Within 90 days post randomization
Secondary outcome [3] 0 0
Vascular mortality
Timepoint [3] 0 0
Within 90 days post randomization
Secondary outcome [4] 0 0
Nonvascular mortality
Timepoint [4] 0 0
Within 90 days post randomization
Secondary outcome [5] 0 0
Myocardial Infarction
Timepoint [5] 0 0
Within 90 days post randomization
Secondary outcome [6] 0 0
Acute Congestive Heart Failure
Timepoint [6] 0 0
Within 90 days post randomization
Secondary outcome [7] 0 0
Stroke
Timepoint [7] 0 0
Within 90 days post randomization
Secondary outcome [8] 0 0
Time from randomization to hospital discharge
Timepoint [8] 0 0
Within 90 days post randomization
Secondary outcome [9] 0 0
Delirium
Timepoint [9] 0 0
Within 7 days and 90 days post randomization
Secondary outcome [10] 0 0
Moderate to severe pain
Timepoint [10] 0 0
Within 7 days and 90 days post randomization

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2027
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The John Hunter Hospital - New Lambton Heights
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussels
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Chile
State/province [14] 0 0
RM
Country [15] 0 0
Chile
State/province [15] 0 0
Santiago
Country [16] 0 0
Finland
State/province [16] 0 0
Lappeenranta
Country [17] 0 0
Finland
State/province [17] 0 0
Tampere
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Hong Kong
Country [19] 0 0
India
State/province [19] 0 0
Delhi
Country [20] 0 0
India
State/province [20] 0 0
Karnataka
Country [21] 0 0
India
State/province [21] 0 0
Kerala
Country [22] 0 0
India
State/province [22] 0 0
Pondicherry
Country [23] 0 0
Italy
State/province [23] 0 0
Milan
Country [24] 0 0
Malaysia
State/province [24] 0 0
Kuala Lumpur
Country [25] 0 0
Mexico
State/province [25] 0 0
Jalisco
Country [26] 0 0
Mexico
State/province [26] 0 0
Chihuahua
Country [27] 0 0
Nepal
State/province [27] 0 0
Bagmati
Country [28] 0 0
Netherlands
State/province [28] 0 0
Overijssel
Country [29] 0 0
Netherlands
State/province [29] 0 0
Amsterdam
Country [30] 0 0
Pakistan
State/province [30] 0 0
ICT
Country [31] 0 0
Pakistan
State/province [31] 0 0
KPK
Country [32] 0 0
Pakistan
State/province [32] 0 0
Punjab
Country [33] 0 0
Pakistan
State/province [33] 0 0
Sindh
Country [34] 0 0
Pakistan
State/province [34] 0 0
Sind
Country [35] 0 0
Poland
State/province [35] 0 0
Malopolska
Country [36] 0 0
Saudi Arabia
State/province [36] 0 0
Riyadh
Country [37] 0 0
South Africa
State/province [37] 0 0
Western Cape
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Malaga
Country [40] 0 0
Spain
State/province [40] 0 0
Valladolid

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Flavia Borges, M.D
Address 0 0
Population Health Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Valerie Harvey
Address 0 0
Country 0 0
Phone 0 0
905-297-3479
Fax 0 0
Email 0 0
valerie.harvey@phri.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04743765