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CTRI Number  CTRI/2022/08/045084 [Registered on: 30/08/2022] Trial Registered Prospectively
Last Modified On: 01/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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 
Scientific Title of Study   HIP fracture Accelerated surgical TreaTment And Care tracK 2 Trial 
Trial Acronym  HIP ATTACK-2 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT04743765  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Alben Sigamani 
Designation  Director 
Affiliation  Carmel Research Consultancy Pvt Ltd 
Address  No 56 1st Cross Residency Layout, Opp Mayo Hall

Bangalore
KARNATAKA
560025
India 
Phone  8884431444  
Fax    
Email  dralbens@myrescon.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Alben Sigamani 
Designation  Director 
Affiliation  Carmel Research Consultancy Pvt Ltd 
Address  No 56 1st Cross Residency Layout, Opp Mayo Hall

Bangalore
KARNATAKA
560025
India 
Phone  8884431444  
Fax    
Email  dralbens@myrescon.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Alben Sigamani 
Designation  Director 
Affiliation  Carmel Research Consultancy Pvt Ltd 
Address  No 56 1st Cross Residency Layout, Opp Mayo Hall

Bangalore
KARNATAKA
560025
India 
Phone  8884431444  
Fax    
Email  dralbens@myrescon.com  
 
Source of Monetary or Material Support  
Population Health Research Institution Hamilton General Hospital Campus, 237 Barton Street East, Hamilton, Ontario Canada L8L 2X2 
 
Primary Sponsor  
Name  Population Health Research Institute 
Address  HIP ATTACK Project Office Population Health Research Institute Hamilton General Hospital Campus DBCVSRI 237 Barton Street East Room C1 243 Hamilton Ontario Canada L8L 2X2 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Belgium
Canada
Finland
India
Mexico
Netherlands
South Africa
Spain
United States of America
Nepal  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijay Sharma  All India Institute of Medical License  Department of Orthopaedics AIIMS Room No.407, 4th Floor,JPNATC New Delhi - 110029
New Delhi
DELHI 		 9899502492

drvijaysharmatrauma@gmail.com 
Dr Niranjan Mallanaik  Bangalore Baptist Hospital   Department of Orthopaedics Bangalore Baptist Hospital Bellary Road Hebbal Bangalore 560024
Bangalore
KARNATAKA 		 9449001918

onsnir@yahoo.co.in 
Dr Prem Haridas Menon  Government Medical College  Division of Orthopaedic surgery and Traumatology Government Medical College, Trivandrum Ulloor - Akkulam Rd, near SAT hospital Medical College Junction, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA 		 9447399970

phmenon777@gmail.com 
Dr Alen Sigamani  Government TD Medical College  NH 66,Vandanam Alappuzha-688005
Alappuzha
KERALA 		 9446010767

alenspeter@yahoo.co.in 
Dr Adinarayanan Sethuramachandran  Jawaharlal Institute of Postgraduate Medical Education & Research  Department of Anaesthesiology and Critical Care JIPMER, Dhanvantri Nagar, Gorimedu 605006
Pondicherry
PONDICHERRY 		 9442396762

adinarayanans@gmail.com 
Dr Parag Sancheti  Sancheti Institute of Orthopedics and Rehabilitation  Department of Orthopaedics, 16, Shivajinagar, Pune 411005
Pune
MAHARASHTRA 		 8888553333

parag@sanchetihospital.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Human Ethics Committee, Medical College Thiruvananthapuram  Approved 
Institute Ethics Committee(Human Studies)-JIPMER Puducherry  Approved 
Institute Ethics Committee-All India Institute of Medical Sciences  Approved 
Institutional Ethics Committe Government TD Medical College  Approved 
Institutional Ethics Committee, Sancheti Institute of Orthopedics and Rehabilitation  Approved 
Institutional Review Board, Bangalore Baptist Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S790||Physeal fracture of upper end of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Accelerated medical clearance and accelerated surgery   If the patient is randomized into the accelerated arm, then the patient will be taken into surgery within 6 hours of his/her arrival at the hospital with a hip fracture  
Comparator Agent  Standard Care   If the patient is randomized into the standard care arm, then the hospital will follow their standard care of treatment for the hip fracture  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
All-cause mortality - Death due to all causes  90 days after randomization 
 
Secondary Outcome  
Outcome  TimePoints 
1.Ability to independently walk 3 meters
2.Composite of major complications
3.Vascular mortality
4.Nonvascular mortality
5.Myocardial Infarction
6.Acute Congestive Heart Failure
7.Stroke
8.Time from randomization to hospital discharge
9.Delirium
10.Moderate to severe pain 		 90 days post randomization.
(9)Delirium and (10)Pain - Within 7 days and 90 days post randomization 
 
Target Sample Size   Total Sample Size="1100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/11/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Patients suffering a hip fracture with an acute myocardial injury are at substantial risk for mortality. The current standard of care is to delay surgery for those patients while additional tests and potential treatments are implemented with the intention of minimizing the risk of post-operative complications. However, there is no RCT data demonstrating that cardiac stabilization and surgical delay are beneficial for these patients. Among the patients with an acute myocardial injury randomized to standard care in the HIP ATTACK-1 trial mortality was more than doubled as compared to patients that underwent accelerated surgery.

There exists a strong biological rationale for how accelerated surgical treatment of a hip fracture and an acute myocardial injury may lower a patient’s risk of death. There is also encouraging data from HIP ATTACK-1 trial suggesting that early surgery for a hip fracture reduces a patient’s risk of mortality. Moreover, the HIP ATTACK-1 trial demonstrated the feasibility of a trial comparing accelerated medical assessment and surgery versus standard care in those patients. Currently, most patients wait more than 24 hours to have surgery after diagnosis of a hip fracture when there is an ongoing myocardial injury. The need for a large adequately powered trial to settle the issue in a clear way that will drive subsequent practice is compelling.

This is the first large trial that may change the paradigm to postpone surgery in patients suffering acute myocardial injuries before surgery, proposing a novel approach to reverse myocardial injury through expedited surgical care.
 
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