Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812352
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2023-03-30
Brief Title:
Supporting Laypeople Addressing Prehospital Hemorrhage Study
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Evaluating Instructional Interventions Supporting Laypeople Addressing Prehospital Hemorrhage Study A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-12
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:
SLAPS
Brief Summary:
It is unknown if bystanders equipped with point-of-care POC instruction are as effective as bystanders with in-person training for bleeding control Therefore POC instructional interventions were developed during this study in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design
Detailed Description:
Road traffic injuries RTIs are the largest contributor to the global trauma burden which disproportionately affects low- and middle-income countries LMICs With a lack of robust emergency medical services EMS there has been increasing reliance on layperson bystanders to respond to RTIs in LMICs called lay first responders LFRs In prospective studies of LFR activity across three sub-Saharan African countries comprising 2039 total patient encounters LFRs most frequently provided hemorrhage control in 61 of patient encounters Rapid hemorrhage control for compressible extremity hemorrhage by bystander LFRs has the potential to mitigate exsanguination reducing mortality secondary to RTIs Rapid hemorrhage control also has applicability to high-income country settings like the United States that sustain high rates of penetrating trauma due to gun violence Rapid hemorrhage control using tourniquets for compressible extremity hemorrhage in patients not yet in shock is strongly associated with saved lives demonstrated in battlefield studies decreasing preventable deaths by more than 50 Bystanders may be trained in-person or point-of-care POC instruction may be provided as exists with automated external defibrillators However it is unknown if bystanders equipped with POC instruction are as effective as bystanders with in-person training for tourniquet application Therefore the investigators developed POC instructional interventions in response to the scalability challenges associated with in-person training to measure comparative effectiveness and skill retention using a randomized controlled trial design
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