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Supporting Laypeople Addressing Prehospital Hemorrhage Study

NCT ID: NCT05812352

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-24

Study Completion Date

2023-12-01

Brief Summary

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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

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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 2,039 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.

Conditions

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Hemorrhage Laceration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Participants are randomized to 1 of 4 educational interventions. Once the initial instructional intervention is completed, participants subsequently present for a 6-month follow-up.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor only enters the laboratory after the participant has attempted to apply the tourniquet. Therefore, the outcomes assessor is unaware of the instructional intervention that was employed. The outcomes assessor will assess (1) tourniquet placement sufficient distance above the injury defined as at least 2 inches proximal to the amputation, (2) turning on an external diaphragm pump that attempts to force water through tubing in the mannequin extremity bypassing the tourniquet.

Study Groups

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Audio recording and instructional flashcard with tourniquet ("audio kit") - 6 month follow-up

MP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application, used for tourniquet application attempt. Participants repeat the tourniquet application attempt with the audio kit at 6 month follow-up

Group Type EXPERIMENTAL

Audio kit

Intervention Type BEHAVIORAL

MP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application

Instructional flashcard with tourniquet - 6 month follow-up

Instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application, used for tourniquet application attempt. Participants repeat the tourniquet application attempt with the instructional flashcard at 6 month follow-up

Group Type EXPERIMENTAL

Instructional flashcard

Intervention Type BEHAVIORAL

Single page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application

In-person training with tourniquet - 6 month follow-up

Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt. Participants repeat the tourniquet application attempt without any POC instruction or re-training at 6 month follow-up

Group Type EXPERIMENTAL

In-person training

Intervention Type BEHAVIORAL

Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt

Control group with no in-person training and no point-of-care instruction access - 6 month follow-up

There is no in-person training or point-of-care (POC) instructional interventions for this group for tourniquet application attempt. Participants repeat the tourniquet application attempt without any in-person training or POC instructional interventions at 6 month follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Audio kit

MP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application

Intervention Type BEHAVIORAL

Instructional flashcard

Single page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application

Intervention Type BEHAVIORAL

In-person training

Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Understand spoken and written English

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role collaborator

LFR International

UNKNOWN

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Zachary Eisner

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zachary Eisner, BS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Patricia Widder, MS

Role: STUDY_DIRECTOR

Washington University in St. Louis - McKelvey School of Engineering

Locations

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Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00229966

Identifier Type: -

Identifier Source: org_study_id