Effect of Trauma Life Support Training Programs on Patient Outcomes

NCT05417243 | Unknown

• 1 other identifier: tern-pilot
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Trauma Injury

Outcome Measures

Primary Outcomes (1)

• All cause mortality within 30 days from the time of arrival to the emergency department

  30 days

Study Arms (3)

Advanced Trauma Life Support (ATLS)

EXPERIMENTAL

Training in ATLS for residents providing trauma care.

Other: Trauma life support training

Primary Trauma Care (PTC)

EXPERIMENTAL

Training in PTC for residents providing trauma care.

Other: Trauma life support training

Standard Care

NO INTERVENTION

Trauma care according to the current standard with no intervention.

Interventions

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.

Advanced Trauma Life Support (ATLS); Primary Trauma Care (PTC)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Doctors For You: collaborator

Study Sites (7)

Postgraduate Institute of Medical Education & Research

Chandigarh, India

RECRUITING

Medica Superspecialty Hospital

Kolkata, India

COMPLETED

Medical College

Kolkata, India

RECRUITING

Sir Nil Ratan Sircar Medical College & Hospital

Kolkata, India

RECRUITING

HBT Medical College And Dr. R N Cooper Municipal General Hospital

Mumbai, India

COMPLETED

King Edward Memorial Seth G. S. Medical College and K.E.M. Hospital

Mumbai, India

COMPLETED

Lokmanya Tilak Municipal Medical College & General Hospital

Mumbai, India

RECRUITING

Related Publications (2)

• 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.

  PMID: 35437251 BACKGROUND

• 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.

  PMID: 41371733 DERIVED

Related Links

• Trauma life support training Effectiveness Research Network website

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Martin Gerdin Wärnberg, MD, PhD

CONTACT

+46 708 53 95 98; martin.gerdin@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Cluster Randomized Trial

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: May 23, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: During 2023

Locations

IN (7)