Wounds and InjuriesADVANCE TRAUMANCT06321419
Effects of Advanced Trauma Life Support® on Adult Trauma Patient Outcomes
A study testing Advanced Trauma Life Support training in people with Wounds and Injuries, run by Karolinska Institutet at 10 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Advanced Trauma Life Support training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,320 participants
- Where
- 10 sitesIndia
- Study dates
- 27 Feb 2025to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age of at least 15 years;
- 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.
Who cannot join
- present with isolated limb injuries; or
- are directly admitted to a ward without being seen by a physician in the emergency department.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
India10 sites, 10 recruiting
- Recruiting
Government Medical College Hospital
Chandigarh, 160030
Rajeev Sharma, MS Neurosurgery
Zahid Mir, General Surgery
- Recruiting
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University
Dehradun, Uttarakhand, 248016
Hemant Nautiyal, MS General Surgery
Bhaskar Bisht, MS General Surgery
- Recruiting
Assam Medical College & Hospital
Dibrugarh, Assam, 786003
Jishan Ahmed, +919435031369, dr.jishan@gmail.com
- Recruiting
Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital (IPGMER and SSKM Hospital)
Kolkata, West Bengal, 700020
Shamita Chatterjee, MS General Surgery
Maitreyee Mukherjee, MD Anaesthesiology
- Recruiting
Dayanand Medical College & Hospital
Ludhiana, Punjab, 141001
Jaspal Singh, +919815599527, jaspalselhi@gmail.com
- Recruiting
Christian Medical College & Hospital
Ludhiana, Punjab, 141008
Parvez Haque, MS General Surgery
Thejus Varghese, MD Emergency
- Recruiting
KEM Hospital
Mumbai, Maharashtra, 400012
Monty Khajanchi, monta32@gmail.com
- Recruiting
Lokmanya Tilak Municipal General Hospital
Mumbai, Maharashtra, 400022
Vineet Kumar, +91 982023133, drvineetkumar@gmail.com
- Recruiting
Hridaysamrat Balasaheb Thackre Mun. Medical college and Dr. R.N. Cooper Hospital
Mumbai, Maharashtra, 400056
Geeta Ghag, MS General Surgery
Vipul Nandu, MS General Surgery
- Recruiting
Holy Family Hospital
New Delhi, New Delhi, 110025
Aisvarya Kapoor, +919999139808, aisvarya.kapoor@gmail.com
About this study
Official title: Effects of Advanced Trauma Life Support® 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.
Read more
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.
- Conditions
- Wounds and Injuries
- Being tested
- Advanced Trauma Life Support training
- Keywords
- Advanced Trauma Life Support, Mortality, Disability, Return to work, Quality of Life
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Trauma Life Support trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Trauma Life Support | Experimental | 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. Receives: Behavioral: Advanced Trauma Life Support training |
| Standard care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality within 30 days of arrival at the emergency department
Clinical research coordinators will extract information on death from patient hospital records. If the patient has been transferred to another hospital, the clinical research coordinators will collect data on this outcome by calling the patient or a patient representative, or by contacting the hospital to which the patient was transferred. Data on this outcome will be collected continuously during the trial.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start27 Feb 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Batched stepped-wedge cluster randomised trial. We will roll out the interventions to 30 clusters over six batches, so there will be five clusters in each batch. The clusters in each batch will be randomised to one of five implementation sequences, with one hospital randomised to each implementation sequence. All clusters will transition through three phases, first a standard care phase, then a one month transition phase during which the training is delivered, and finally an intervention phase, for a total of 13 months.
- Masking
- None (open label)
- Enrolment
- 4,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The George Institute
- Responsible party
- Principal investigator, Martin Gerdin, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321419
- Sponsor's protocol ID
- atls-vs-standard-care
- Acronym
- ADVANCE TRAUMA
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ranjan S, Falth S, Kharat P, Bassi A, Bakhshi GD, Basak D, Berg J, Chatterjee S, Fellander-Tsai L, Hemming K, Jha V, Kasza J, Khajanchi M, Martin J, Mishra A, Olofsson A, Roy N, Singh R, Soni KD, Gerdin Warnberg M. Effects of Advanced Trauma Life Support(R) training compared with standard care on adult trauma patient outcomes (ADVANCE TRAUMA): study protocol for a stepped-wedge cluster randomised trial. Trials. 2026 Feb 3;27(1):176. doi: 10.1186/s13063-026-09491-z.
PubMed 41630085
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Advanced Trauma Life Support® Training Compared to Standard Care on Adult Trauma Patient Outcomes: A Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT06321419
- Acronym / sponsor ID
- ADVANCE TRAUMA / atls-vs-standard-care
- Conditions
- Wounds and Injuries
- Keywords
- Advanced Trauma Life Support, Mortality, Disability, Return to work, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,320 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The George Institute
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Batched stepped-wedge cluster randomised trial. We will roll out the interventions to 30 clusters over six batches, so there will be five clusters in each batch. The clusters in each batch will be randomised to one of five implementation sequences, with one hospital randomised to each implementation sequence. All clusters will transition through three phases, first a standard care phase, then a one month transition phase during which the training is delivered, and finally an intervention phase, for a total of 13 months.
| Arm | Type | Receives |
|---|---|---|
| Advanced Trauma Life Support | Experimental | Behavioral: Advanced Trauma Life Support trainingThe 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. |
| Standard care | No intervention | –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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age of at least 15 years;
- 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.
Key exclusion criteria (2 listed)
- present with isolated limb injuries; or
- are directly admitted to a ward without being seen by a physician in the emergency department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Trauma Life Support trainingAdvanced 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. | Behavioural | Advanced Trauma Life Support |
Primary outcome
In-hospital mortality within 30 days of arrival at the emergency department
Time frame: 30 days
Clinical research coordinators will extract information on death from patient hospital records. If the patient has been transferred to another hospital, the clinical research coordinators will collect data on this outcome by calling the patient or a patient representative, or by contacting the hospital to which the patient was transferred. Data on this outcome will be collected continuously during the trial.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 41630085Ranjan S, Falth S, Kharat P, Bassi A, Bakhshi GD, Basak D, Berg J, Chatterjee S, Fellander-Tsai L, Hemming K, Jha V, Kasza J, Khajanchi M, Martin J, Mishra A, Olofsson A, Roy N, Singh R, Soni KD, Gerdin Warnberg M. Effects of Advanced Trauma Life Support(R) training compared with standard care on adult trauma patient outcomes (ADVANCE TRAUMA): study protocol for a stepped-wedge cluster randomised trial. Trials. 2026 Feb 3;27(1):176. doi: 10.1186/s13063-026-09491-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Trauma Life Support training in people with Wounds and Injuries, run by Karolinska Institutet at 10 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Gerdin Wärnberg, PhD (+46708539598, martin.gerdin@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality within 30 days of arrival at the emergency department (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06321419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.