ATLS vs Standard Care Trial

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06321419
• Other study ID #: atls-vs-standard-care
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: November 2029

Study information

• Verified date: June 2024
• Source: Karolinska Institutet
• Contact: Martin Gerdin Wärnberg, PhD
• Phone: +46 (0)8-524 800 00
• Email: martin.gerdin[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4320
• Est. completion date: November 2029
• Est. primary completion date: November 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Behavioral:
• Advanced Trauma Life Support training
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	The George Institute for Global Health, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be 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.	30 days