Trauma InjuryNCT05417243
Effect of Trauma Life Support Training Programs on Patient Outcomes
A study testing Trauma life support training in people with Trauma Injury, run by Karolinska Institutet at 7 sites in India.
Trial summary
Introduction: Trauma accounts for nearly 10% of the global burden of disease. Several trauma life support programs aim to improve trauma outcomes. There is no evidence from controlled trials to show the effect of these programs on patient outcomes. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Trauma life support training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 7 sitesIndia
- Study dates
- 23 May 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults (15 years or older) who present to the emergency department at participating hospitals with a history of trauma. History of trauma is here defined as having any of the external causes of morbidity and mortality listed in block V01-Y36, chapter XX of the International Classification of Disease version 10 (ICD-10) codebook as reason for presenting.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites, 4 recruiting
- Recruiting
Postgraduate Institute of Medical Education & Research
Chandigarh
- Completed
Medica Superspecialty Hospital
Kolkata
- Recruiting
Medical College
Kolkata
- Recruiting
Sir Nil Ratan Sircar Medical College & Hospital
Kolkata
- Completed
HBT Medical College And Dr. R N Cooper Municipal General Hospital
Mumbai
- Completed
King Edward Memorial Seth G. S. Medical College and K.E.M. Hospital
Mumbai
- Recruiting
Lokmanya Tilak Municipal Medical College & General Hospital
Mumbai
About this study
Official title: A Pilot Multicentre Cluster Randomised Trial to Compare the Effect of Trauma Life Support Training Programmes on Patient and Provider Outcomes
Introduction:
Trauma accounts for nearly 10% of the global burden of disease. Several trauma life support programs aim to improve trauma outcomes. There is no evidence from controlled trials to show the effect of these programs on patient outcomes. We describe the protocol of a pilot study that aims to assess the feasibility of conducting a cluster randomised controlled trial comparing Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care.
Read more
Methods and analysis:
We will pilot a pragmatic three-armed parallel, cluster randomised, controlled trial in India, where neither of these programs are routinely taught. We will recruit tertiary hospitals and include trauma patients and residents managing these patients. Two hospitals will be randomised to ATLS, two to PTC, and two to standard care. The primary outcome will be all cause mortality at 30 days from the time of arrival to the emergency department. Our secondary outcomes will include patient, provider, and process measures. All outcomes except time to event outcomes will be measured both as final values as well as change from baseline. We will compare outcomes in three combinations of trial arms: ATLS versus PTC, ATLS versus standard care, and PTC versus standard care using absolute and relative differences along with associated confidence intervals. We will conduct subgroup analyses across the clinical subgroups men, women, blunt multisystem trauma, penetrating trauma, shock, severe traumatic brain injury, and elderly. In parallel to the pilot study we will conduct community consultations to inform the planning of the full-scale trial.
- Conditions
- Trauma Injury
- Being tested
- Trauma life support training
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma life support trainingOther
Clusters are randomised for their residents to be trained in one of two trauma life support training programs or to continue providing standard care.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Trauma Life Support (ATLS) | Experimental | Training in ATLS for residents providing trauma care. Receives: Other: Trauma life support training |
| Primary Trauma Care (PTC) | Experimental | Training in PTC for residents providing trauma care. Receives: Other: Trauma life support training |
| Standard Care | No intervention | Trauma care according to the current standard with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality within 30 days from the time of arrival to the emergency department
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 posted14 Jun 2022
- Study start23 May 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies 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
- Parallel groups
- Model description
- Cluster Randomized Trial
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Doctors For You
- Responsible party
- Principal investigator, Martin Gerdin, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417243
- Sponsor's protocol ID
- tern-pilot
- Status last verified
- Nov 2022
- First submitted
- 9 Jun 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final anonymized dataset and code for analysis will be released publicly.
Publications
Gerdin Warnberg M, Berg J, Bhandarkar P, Chatterjee A, Chatterjee S, Chintamani C, Fellander-Tsai L, Gadgil A, Ghag G, Hasselberg M, Juillard C, Khajanchi M, Kizhakke Veetil D, Kumar V, Kundu D, Mishra A, Patil P, Roy N, Roy A, David S, Singh R, Solomon H, Soni KD, Strommer L, Tandon M; Trauma life support training Effectiveness Research Network (TERN) collaborators. A pilot multicentre cluster randomised trial to compare the effect of trauma life support training programmes on patient and provider outcomes. BMJ Open. 2022 Apr 18;12(4):e057504. doi: 10.1136/bmjopen-2021-057504.
PubMed 35437251Gerdin Warnberg M, Basak D, Berg J, Chatterjee S, Fellander-Tsai L, Ghag G, Juillard C, Khajanchi M, Khan T, Mishra A, Nandu VV, Roy N, Singh R, Soni KD, Strommer L. Feasibility of a cluster randomised trial on the effect of trauma life support training: a pilot study in India. BMJ Open. 2025 Dec 10;15(12):e099020. doi: 10.1136/bmjopen-2025-099020.
PubMed 41371733
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Multicentre Cluster Randomised Trial to Compare the Effect of Trauma Life Support Training Programmes on Patient and Provider Outcomes
- ClinicalTrials.gov ID
- NCT05417243
- Acronym / sponsor ID
- tern-pilot
- Conditions
- Trauma Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Doctors For You
- Study start
- 23 May 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 14 Jun 2022 (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.
Introduction:
Trauma accounts for nearly 10% of the global burden of disease. Several trauma life support programs aim to improve trauma outcomes. There is no evidence from controlled trials to show the effect of these programs on patient outcomes. We describe the protocol of a pilot study that aims to assess the feasibility of conducting a cluster randomised controlled trial comparing Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care.
Methods and analysis:
We will pilot a pragmatic three-armed parallel, cluster randomised, controlled trial in India, where neither of these programs are routinely taught. We will recruit tertiary hospitals and include trauma patients and residents managing these patients. Two hospitals will be randomised to ATLS, two to PTC, and two to standard care. The primary outcome will be all cause mortality at 30 days from the time of arrival to the emergency department. Our secondary outcomes will include patient, provider, and process measures. All outcomes except time to event outcomes will be measured both as final values as well as change from baseline. We will compare outcomes in three combinations of trial arms: ATLS versus PTC, ATLS versus standard care, and PTC versus standard care using absolute and relative differences along with associated confidence intervals. We will conduct subgroup analyses across the clinical subgroups men, women, blunt multisystem trauma, penetrating trauma, shock, severe traumatic brain injury, and elderly. In parallel to the pilot study we will conduct community consultations to inform the planning of the full-scale trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Advanced Trauma Life Support (ATLS) | Experimental | Other: Trauma life support trainingTraining in ATLS for residents providing trauma care. |
| Primary Trauma Care (PTC) | Experimental | Other: Trauma life support trainingTraining in PTC for residents providing trauma care. |
| Standard Care | No intervention | –Trauma care according to the current standard with no intervention. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (15 years or older) who present to the emergency department at participating hospitals with a history of trauma. History of trauma is here defined as having any of the external causes of morbidity and mortality listed in block V01-Y36, chapter XX of the International Classification of Disease version 10 (ICD-10) codebook as reason for presenting.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Trauma life support trainingClusters are randomised for their residents to be trained in one of two trauma life support training programs or to continue providing standard care. | Other | Advanced Trauma Life Support (ATLS), Primary Trauma Care (PTC) |
Primary outcome
All cause mortality within 30 days from the time of arrival to the emergency department
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Background: PubMed 35437251Gerdin Warnberg M, Berg J, Bhandarkar P, Chatterjee A, Chatterjee S, Chintamani C, Fellander-Tsai L, Gadgil A, Ghag G, Hasselberg M, Juillard C, Khajanchi M, Kizhakke Veetil D, Kumar V, Kundu D, Mishra A, Patil P, Roy N, Roy A, David S, Singh R, Solomon H, Soni KD, Strommer L, Tandon M; Trauma life support training Effectiveness Research Network (TERN) collaborators. A pilot multicentre cluster randomised trial to compare the effect of trauma life support training programmes on patient and provider outcomes. BMJ Open. 2022 Apr 18;12(4):e057504. doi: 10.1136/bmjopen-2021-057504.
- Derived from this study: PubMed 41371733Gerdin Warnberg M, Basak D, Berg J, Chatterjee S, Fellander-Tsai L, Ghag G, Juillard C, Khajanchi M, Khan T, Mishra A, Nandu VV, Roy N, Singh R, Soni KD, Strommer L. Feasibility of a cluster randomised trial on the effect of trauma life support training: a pilot study in India. BMJ Open. 2025 Dec 10;15(12):e099020. doi: 10.1136/bmjopen-2025-099020.
- Trauma life support training Effectiveness Research Network websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The final anonymized dataset and code for analysis will be released publicly.
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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. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma life support training in people with Trauma Injury, run by Karolinska Institutet at 7 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Gerdin Wärnberg, MD, PhD (+46 708 53 95 98, martin.gerdin@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality within 30 days from the time of arrival to 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 NCT05417243, which also lists 2 linked publications.
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 9 Nov 2022.