Effects of Advanced Trauma Life Support® on Adult Trauma Patient Outcomes
NCT ID: NCT06321419
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4320 participants
INTERVENTIONAL
2025-02-27
2029-11-30
Brief Summary
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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.
Trial Population:
Adult trauma patients presenting to the emergency department of a participating hospital.
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.
Ethical Considerations:
The study will use an opt-out consent approach for in-hospital collection of routinely recorded data, in which consent is presumed unless actively declined. Informed consent for non-routinely recorded data including out of hospital follow up will be obtained. 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, as it will not be possible for patients to opt out from being subjected to the intervention. This approach is justified because the trial can be considered to involve only minimal risk and the data collection is non-invasive and mostly involve extracting routinely collected data from medical records.
Funding:
Swedish Research Council (reg. no. 2023-03128), Laerdal Foundation (reg. no. 2023-0297).
Special considerations:
This trial is not yet fully funded. The Trial Management Group has decided to proceed with the trial with the expectation that additional funding will be secured. The Joint Trial Steering and Data Monitoring Committee will be informed of the funding status at each meeting. If funding is not secured, the trial will be stopped. This will likely result in an underpowered trial. The justification for this decision is that the intervention is considered standard of care in many countries and the data collection is considered minimal risk. There is therefore a very small risk of harm to patient participants, but a potential direct benefit to those.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Advanced Trauma Life Support
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.
Advanced Trauma Life Support training
Advanced Trauma Life Support (ATLS) is a proprietary 2.5 day course teaching a standardised approach to trauma patient care using the concepts of a primary and secondary survey. The programme was developed by the Committee of Trauma of the American College of Surgeons. The course includes intial treatment and resuscitation, triage and interfacility transfers. Leaning is based on practical scenario-driven skill stations, lectures and includes a final performance proficiency evaluation. Physicians will be trained in an accredited ATLS training facility in India.
Standard care
Standard care varies across hospitals in India, but trauma patients are initially managed by casualty medical officers, surgical residents, or emergency medicine residents. They are mainly first- or second-year residents who resuscitate patients, perform interventions and refer patients for imaging or other investigations. Compared with other settings where a trauma team approach is adopted, nurses and other healthcare professionals are only involved to a limited extent during the initial management.
No interventions assigned to this group
Interventions
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Advanced Trauma Life Support training
Advanced Trauma Life Support (ATLS) is a proprietary 2.5 day course teaching a standardised approach to trauma patient care using the concepts of a primary and secondary survey. The programme was developed by the Committee of Trauma of the American College of Surgeons. The course includes intial treatment and resuscitation, triage and interfacility transfers. Leaning is based on practical scenario-driven skill stations, lectures and includes a final performance proficiency evaluation. Physicians will be trained in an accredited ATLS training facility in India.
Eligibility Criteria
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Inclusion Criteria
* trauma occurred less than 48 hours before arrival at the hospital;
* 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;
* 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; and
* managed by a participating cluster in the emergency department.
Exclusion Criteria
* are directly admitted to a ward without being seen by a physician in the emergency department.
15 Years
ALL
No
Sponsors
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The George Institute
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Martin Gerdin
Principal Researcher
Locations
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Assam Medical College & Hospital
Dibrugarh, Assam, India
KEM Hospital
Mumbai, Maharashtra, India
Lokmanya Tilak Municipal General Hospital
Mumbai, Maharashtra, India
Hridaysamrat Balasaheb Thackre Mun. Medical college and Dr. R.N. Cooper Hospital
Mumbai, Maharashtra, India
Holy Family Hospital
New Delhi, New Delhi, India
Dayanand Medical College & Hospital
Ludhiana, Punjab, India
Christian Medical College & Hospital
Ludhiana, Punjab, India
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University
Dehradun, Uttarakhand, India
Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital (IPGMER and SSKM Hospital)
Kolkata, West Bengal, India
Government Medical College Hospital
Chandigarh, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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atls-vs-standard-care
Identifier Type: -
Identifier Source: org_study_id
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