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| Name | Class |
|---|---|
| Doctors For You | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Trauma Life Support (ATLS) | Experimental | Training in ATLS for residents providing trauma care. |
|
| Primary Trauma Care (PTC) | Experimental | Training in PTC for residents providing trauma care. |
|
| Standard Care | No Intervention | Trauma care according to the current standard with no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma life support training | Other | Clusters are randomised for their residents to be trained in one of two trauma life support training programs or to continue providing standard care. |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality within 30 days from the time of arrival to the emergency department | 30 days |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Gerdin Wärnberg, MD, PhD | Contact | +46 708 53 95 98 | martin.gerdin@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Institute of Medical Education & Research | Recruiting | Chandigarh | India | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35437251 | Background | 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. | |
| 41371733 |
| Label | URL |
|---|---|
| Trauma life support training Effectiveness Research Network website | View source |
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The final anonymized dataset and code for analysis will be released publicly.
During 2023
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| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Cluster Randomized Trial
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| Medica Superspecialty Hospital |
| Completed |
| Kolkata |
| India |
| Medical College | Recruiting | Kolkata | India |
| Sir Nil Ratan Sircar Medical College & Hospital | Recruiting | Kolkata | India |
| HBT Medical College And Dr. R N Cooper Municipal General Hospital | Completed | Mumbai | India |
| King Edward Memorial Seth G. S. Medical College and K.E.M. Hospital | Completed | Mumbai | India |
| Lokmanya Tilak Municipal Medical College & General Hospital | Recruiting | Mumbai | India |
| Derived |
| Gerdin 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. |