Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321419
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-03-14
Brief Title:
Effects of Advanced Trauma Life Support on Adult Trauma Patient Outcomes
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Effects of Advanced Trauma Life Support Training Compared to Standard Care on Adult Trauma Patient Outcomes A Cluster Randomised Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADVANCE TRAUMA
Brief 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 refertransfer 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
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 refertransfer 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None