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CTRI Number  CTRI/2024/07/071336 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 04/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Cluster Randomized Trial 
Public Title of Study   A study on effects of ALTS training for trauma physicians and its impact on in-hospital mortality.  
Scientific Title of Study   Effects of Advanced Trauma Life Support Training Compared to Standard Care on Adult Trauma Patient Outcomes A Cluster Randomised Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivekanand Jha 
Designation  Executive Director  
Affiliation  The George Institute for Global Health, India 
Address  The George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre New Delhi DELHI India

South
DELHI
110025
India 
Phone  911141588091  
Fax  911141588090  
Email  vjha@georgeinstitute.org.in  
 
Details of Contact Person
Scientific Query  
Name  Abhinav Bassi 
Designation  Co-Investigator 
Affiliation  The George Institute for Global Health, India 
Address  The George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre New Delhi DELHI India

South
DELHI
110025
India 
Phone  911141588091  
Fax    
Email  abassi@georgeinstitute.org.in  
 
Details of Contact Person
Public Query  
Name  Abhinav Bassi 
Designation  Co-Investigator 
Affiliation  The George Institute for Global Health, India 
Address  The George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre New Delhi DELHI India

South
DELHI
110025
India 
Phone  911141588091  
Fax    
Email  abassi@georgeinstitute.org.in  
 
Source of Monetary or Material Support  
Karolinska Institutet, 171 77 Stockholm, Sweden  
 
Primary Sponsor  
Name  Martin Gerdin Wärnberg  
Address  Karolinska Institutet, 171 77 Stockholm 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Parvez David Haque  Christian Medical College-Ludhiana  Christian Medical College and Hospital Brown Road
Ludhiana
PUNJAB 		 9872630178

pdhaque@gmail.com 
Dr Geeta Ghag  Dr RN Cooper Hospital and HBT Medical College  Department of General Surgery Dr RN Cooper Hospital Juhu Vile-Parle-West Mumbai
Mumbai (Suburban)
MAHARASHTRA 		 9869381862

geetaghag@hotmail.com 
Dr Rajeev Sharma  Government Medical College Chandigarh  Sector-32 Chandigarh
Chandigarh
CHANDIGARH 		 91-172-2601023

rjvsharma63@gmail.com 
Dr Hemant Nautiyal  Himalayan Institute of Medical Sciences   Himalayan Institute of Medical Sciences Swami Ram Nagar Jollygrant Dehradun Dehradun
Dehradun
UTTARANCHAL 		 9410507100

drnauty1@gmail.com 
Dr Amit Roy  Nilratan Sircar Medical College & Hospital  138 Acharya Jagdish Chandra Bose Rd Sealdah Raja Bazar Kolkata West Bengal 700014 India
Kolkata
WEST BENGAL 		 9830403360

amitranjushree@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee Swami Rama Himalayan University  Approved 
Institutional Ethics Committee Christian Medical College and Hospital  Approved 
Institutional Ethics Committee Govt. Medical College and Hospital Sector 32 Chandigarh  Approved 
INSTITUTIONAL ETHICS COMMITTEE NIL RATAN SIRCAR MEDICAL COLLEGE AND HOSPITAL  Submittted/Under Review 
Institutional Ethics Committee of IPGME&R  Approved 
Institutional Ethics Committee, HBTMC and Dr. R.N Cooper General Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Advanced Trauma Life Support® Training   The intervention will be ATLS® training, a proprietary 2.5 day course teaching a standardised approach to trauma patient care using the concepts of a primary and secondary survey. Physicians will be trained in an accredited ATLS training facility in India. Each site will be included in the study for the total duration of 13 months with a total intervention period of 6 months.  
Comparator Agent  Standard care   Standard care-meaning no formal trauma life support training.Each site will be included in the study for the total duration of 13 months with a total intervention period of 6 months.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age of at least 15 years.
2. Present to the emergency department of participating hospitals with a history of trauma defined as having any of the reasons listed in the International Classification of Diseases chapter XX as the reason for presenting.
3. Admitted or died between arrival at the hospital and admission, or referred/transferred from the emergency department of a participating hospital to another hospital for admission.
4. Trauma occurred less than 48 hours before arrival at the hospital.
 
 
ExclusionCriteria 
Details  Patients participants are excluded if they meet the following criteria:
1) present with isolated limb injuries; or
2) are directly admitted to a ward without being seen by a physician in the emergency department.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be all-cause mortality.   within 30 days of arrival at the emergency department. 
 
Secondary Outcome  
Outcome  TimePoints 
All-cause mortality   within 24 hours and 3 months of arrival at the emergency department.  
In-hospital mortality  within 30 days of arrival at the emergency department.  
Quality of life (EQ5D3L)  within 7 days of discharge, and at 30 days and 3 months of arrival at the emergency department. 
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)   within 7 days of discharge, and at 30 days and 3 months of arrival at the emergency department. 
Return to work   30 days and 3 months after arrival at the emergency department. 
Length of emergency department stay  Data on this outcome will be collected from patient hospital records. 
Length of hospital stay  Data on this outcome will be collected from patient hospital records. 
Intensive care unit admission  Data on this outcome will be collected from patient hospital records. 
Length of intensive care unit stay  Data on this outcome will be collected from patient hospital records. 
 
Target Sample Size   Total Sample Size="4320"
Sample Size from India="4320" 
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   Phase 3 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Title: Effects of Advanced Trauma Life Support Â® Training Compared to Standard Care on Adult Trauma Patient Outcomes: A Cluster Randomised Trial

Rationale: Trauma is a massive global health issue. Many training programmes have been developed to help physicians in the initial management of trauma patients. Among these programmes, Advanced Trauma Life Support® (ATLS®) is the most popular, having trained over one million physicians worldwide. Despite its widespread use, there are no controlled trials showing that ATLS® improves patient outcomes. Multiple systematic reviews emphasise the need for such trials.

Aim: To compare the effects of ATLS® training with standard care on outcomes in adult trauma patients.

Primary Outcome: All-cause mortality within 30 days of arrival at the emergency department.

Trial Design: Batched stepped-wedge cluster randomised trial in India.

Trial Population: Adult trauma patients presenting to the emergency department of a participating hospital.

Sample Size: 30 clusters and 4320 patients.

Eligibility Criteria

Hospitals are secondary or tertiary hospitals in India that admit or refer/transfer for admission at least 400 patients with trauma per year.

Clusters are one or more units of physicians providing initial trauma care in the emergency department of tertiary hospitals in India.

Patients participants are adult trauma patients who presents to the emergency department of participating hospitals and are admitted or transferred for admission.

Intervention: The intervention will be ATLS Â® training, a proprietary 2.5 day course teaching a standardised approach to trauma patient care using the concepts of a primary and secondary survey. Physicians will be trained in an accredited ATLS Â® training facility in India.

Ethical Consideration:s We will use an opt-out consent approach for collection of routinely recorded data. We will obtain informed consent for collection of non-routinely recorded data, such as quality of life and disability outcomes. Patients who are unconscious or lack a legally authorized representative will be included under a waiver of informed consent. Note that consent here refers to consent to data collection.

Trial Period: 2024 to 2029

 
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