Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001054505
Ethics application status
Approved
Date submitted
7/08/2024
Date registered
30/08/2024
Date last updated
30/08/2024
Date data sharing statement initially provided
30/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Stopping Haemorrhage by Application of Randomised Compression or Tourniquet (SHARC-TWO)
Scientific title
Comparison of inguinal fist compression versus commercial windlass tourniquet for reduction in femoral artery blood flow by untrained providers: a superiority, assessor-blinded, cross-over, randomised controlled trial
Secondary ID [1] 312472 0
None
Universal Trial Number (UTN)
U1111-1312-3053
Trial acronym
SHARC-TWO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb arterial haemorrhage 334657 0
Condition category
Condition code
Emergency medicine 331233 331233 0 0
Other emergency care
Injuries and Accidents 331234 331234 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inguinal Fist Compression (IFC)
The provider will place the fist of their dominant hand at the midpoint of the recipient’s inguinal canal, midway between the anterior superior iliac spine and the pubic symphysis. The leg used (left or right) for each data collection session will be determined by the ergonomics of each testing space and will be recorded. Maximal pressure will then be applied over the compression point as per the technique reported by Taylor and Lamond for up to five minutes (see below for complete description of this technique from the original paper).

Commercially manufactured windlass tourniquet (CWT)
The CWT used will be the Combat Application Tourniquet manufactured by C-A-T Resources. The provider will apply the CWT to the upper thigh of the recipient and the windlass rotated to and locked at the maximum tolerable tightness for the recipient. Application of the CWT will be over clothing as to emulate real world ultilsation for up to five minutes.

Infographics
Separate infographics were developed for the IFC and CWT which outline step-by-step instructions on the application of each intervention. The IFC infographic was adapted from the that used in the study conducted by Taylor and Lamond. The CWT infographic was adapted from the manufacturer’s instructions. Both infographics were tested in an initial pilot study and further developed with input from a consumer advisory group with members of the general population. Providers in this study will be exposed to these infographics immediately prior to application of each technique and also be available for reference during their application. Members of the research team will be supervising each episode of technique application but will not interfere or coach providers unless there is a concern for participant safety.

There will be a 2-3 minute washout period between application by each provide during which the room will be reset and the sonographer will ensure return of normal blood flow to the leg.

The protocol for inguinal compression from Taylor and Lamond (The SHARC study) was as follows:
One member of the pair wearing shorts lay down supine on a mattress on the floor. The other volunteer in the pair then placed their fist at the compression point (midpoint of the inguinal canal, midway between the anterior superior iliac spine [ASIS] and pubic symphysis).
Compression was then performed by the volunteer, by applying full bodyweight pressure through their fist over the compression point.
Intervention code [1] 329201 0
Treatment: Devices
Comparator / control treatment
Participants will act as their own control by providing both interventions in a randomise order. They will then act as the recipient after this. Seperate eligibility criteria apply to being a provider and recipient.
Control group
Active

Outcomes
Primary outcome [1] 339005 0
The trial's primary outcome is the reduction in peak systolic velocity (PSV) of the superficial femoral artery (SFA) at 5 minutes post application of the intervention (inguinal fist compression or commercial windlass tourniquet), expressed as a percentage.
Timepoint [1] 339005 0
The PSV will be measured immediately prior to, and five minutes after the application of each intervention.
Secondary outcome [1] 438256 0
Time to apply intervention
Timepoint [1] 438256 0
Recorded as time from infographic exposure until application of intervention, as indicated by the provider.
Secondary outcome [2] 438257 0
Blood flow reduction over time.
Timepoint [2] 438257 0
PSV measurements will be taken at baseline (preintervention), immediately post application of the intervention (0 minutes), and at minutely intervals until 5 minutes (i.e. 1, 2, 3, 4, 5 minutes) post application.
Secondary outcome [3] 438258 0
Complete occlusion: the proportion of recipients with complete occlusion of blood flow at five minutes
Timepoint [3] 438258 0
Five minutes post application of each intervention.
Secondary outcome [4] 438339 0
Provider reported technique preference
Timepoint [4] 438339 0
Immediately following release of each technique.
Secondary outcome [5] 438340 0
Recipient reported technique preference.
Timepoint [5] 438340 0
Immediately following release of each technique.
Secondary outcome [6] 438341 0
Adverse outcomes
Timepoint [6] 438341 0
Immediately following each application, on completion of participation and within 48 hours of participation.
Secondary outcome [7] 438939 0
Duration of complete occlusion (PSV = 0cm/s) in minutes.
Timepoint [7] 438939 0
Minutely intervals from application of each technique, up to five minutes.

Eligibility
Key inclusion criteria
Aged between 18-59 years (inclusive)
English language fluency (including as a second language)
No formal medical training beyond first-aid
No training in arterial tourniquet application
Minimum age
18 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For providers:
Diagnosis, or evidence of, conditions that could potentially be exacerbated by participation as a provider:
Musculoskeletal e.g., carpal tunnel syndrome, previous shoulder dislocation or surgery (e.g. reconstruction), recent injury

For recipients:
Diagnosis, or evidence of, conditions that could potentially be exacerbated by participation as a recipient
Musculoskeletal e.g. previous groin surgery (e.g. hernia repair, hip replacement), recent injury
Vascular e.g. arterial venous malformation or aneurysmal disease of the femoral artery; peripheral vascular disease, including PSV of the SFA outside the normal reference range
Neurological e.g. peripheral nerve disease
Haematological e.g.hypercoagulability, coagulopathy or anticoagulation
Dermatological e.g. severe dermatitis, infection or sunburn

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After consenting, eligible participants will be enrolled into the trial by a member of the research team who will then allocate the order that the interventions will be applied, as determined by the Griffith Randomisation Service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of the interventions performed by each provider will be dictated by the web-based Griffith Randomisation Service. This is a centralised, computer-generated algorithm with randomisation performed in a 1:1 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuous data will be summarised as mean (standard deviation), or median (interquartile range) and categorical data will be summarised as frequency (percentage). Differences between interventions in continuous outcomes, including the primary outcome of percentage reduction in PSV, will be analysed using paired t-tests, or the Wilcoxon signed rank test if normality assumptions are violated. The primary outcome will be tested for superiority of the IFC intervention. The null hypothesis of no difference in PSV reduction between interventions will be rejected if the p-value for this outcome is less than 0.05. Additional testing for period or carryover effects will be performed using Analysis of Variance. The effect of provider and recipient factors on the primary outcome will be assessed using a mixed-effects model, with the parameter of interest included as a fixed effect. Significance testing for categorical outcomes will be performed using Fisher’s Exact Test. All data will be analysed using Stata v14.2 or later.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 316888 0
Charities/Societies/Foundations
Name [1] 316888 0
Emergecy Medicine Foundation
Country [1] 316888 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 319139 0
University
Name [1] 319139 0
Bond University
Address [1] 319139 0
Country [1] 319139 0
Australia
Other collaborator category [1] 283129 0
Hospital
Name [1] 283129 0
Canberra Health Services
Address [1] 283129 0
Country [1] 283129 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315652 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 315652 0
Ethics committee country [1] 315652 0
Australia
Date submitted for ethics approval [1] 315652 0
14/07/2022
Approval date [1] 315652 0
20/01/2023
Ethics approval number [1] 315652 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135378 0
Dr Kimberley Bruce
Address 135378 0
Gold Coast University Hospital, 1 Hospital Blvd, Southport, 4215, QLD
Country 135378 0
Australia
Phone 135378 0
+61 416007872
Fax 135378 0
Email 135378 0
[email protected]
Contact person for public queries
Name 135379 0
Kimberley Bruce
Address 135379 0
Gold Coast University Hospital, 1 Hospital Blvd, Southport, 4215, QLD
Country 135379 0
Australia
Phone 135379 0
+61 7 5687 5076
Fax 135379 0
Email 135379 0
[email protected]
Contact person for scientific queries
Name 135380 0
Kimberley Bruce
Address 135380 0
Gold Coast University Hospital, 1 Hospital Blvd, Southport, 4215, QLD
Country 135380 0
Australia
Phone 135380 0
+61 416007872
Fax 135380 0
Email 135380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data (of published results only) will be available on reasonable request.
When will data be available (start and end dates)?
For a period of five years following publication of the trial.
Available to whom?
For scientific purposes to other researchers.
Available for what types of analyses?
For secondary review or analysis.
How or where can data be obtained?
On request to the PI - via email ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24079Study protocol    Unpublished 388080-(Uploaded-07-08-2024-12-08-43)-SHARC-TWO V4 Protocol clean2.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.