Impact of Advanced Trauma Life Support on outcomes for trauma patients

Effects of Advanced Trauma Life Support® Training Compared to Standard Care on Adult Trauma Patient Outcomes: A Cluster Randomised Trial

This study tests if training doctors in Advanced Trauma Life Support can help adult trauma patients in India recover better and have improved outcomes compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 4320 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: Karolinska Institutet (Academic / other)
• Locations: 10 sites (Dibrugarh, Assam and 9 other locations)
• Trial ID: NCT06321419 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of Advanced Trauma Life Support (ATLS) training compared to standard care in improving outcomes for adult trauma patients. It will involve adult patients presenting to emergency departments of participating hospitals in India, where physicians trained in ATLS will manage their care. The study will assess various outcomes, including mortality, disability, return to work, and quality of life, to determine if ATLS training leads to better patient results.

Who should consider this trial

Good fit: Ideal candidates for this study are adult trauma patients aged 15 years and older who present to the emergency department within 48 hours of their injury.

Not a fit: Patients with isolated limb injuries or those directly admitted to a ward without emergency department evaluation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and quality of life for trauma patients through enhanced training for healthcare providers.

How similar studies have performed: While ATLS is widely used, this study is novel as it seeks to provide controlled evidence of its effectiveness in improving patient outcomes.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* present with isolated limb injuries; or
* are directly admitted to a ward without being seen by a physician in the emergency department.

Where this trial is running

Dibrugarh, Assam and 9 other locations

• Assam Medical College & Hospital — Dibrugarh, Assam, India (Recruiting)
• KEM Hospital — Mumbai, Maharashtra, India (Recruiting)
• Lokmanya Tilak Municipal General Hospital — Mumbai, Maharashtra, India (Recruiting)
• Hridaysamrat Balasaheb Thackre Mun. Medical college and Dr. R.N. Cooper Hospital — Mumbai, Maharashtra, India (Recruiting)
• Holy Family Hospital — New Delhi, New Delhi, India (Recruiting)
• Dayanand Medical College & Hospital — Ludhiana, Punjab, India (Recruiting)
• Christian Medical College & Hospital — Ludhiana, Punjab, India (Recruiting)
• Himalayan Institute of Medical Sciences, Swami Rama Himalayan University — Dehradun, Uttarakhand, India (Recruiting)
• Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital (IPGMER and SSKM Hospital) — Kolkata, West Bengal, India (Recruiting)
• Government Medical College Hospital — Chandigarh, India (Recruiting)

Study contacts

• Study coordinator: Martin Gerdin Wärnberg, PhD

Conditions Wounds and Injuries; Advanced Trauma Life Support; Mortality; Disability; Return to work; Quality of Life