HemorrhageNCT04870814
Comparison of 4 Tactical Tourniquets Used in War Medicine
A study testing Tactical tourniquet set up, Medical ultrasound and Questionnaire in people with Hemorrhage, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
Bleeding remains the leading cause of death in combat, and the literature suggests that tourniquetable hemorrhage is the second leading cause of preventable death, behind non- tourniquetable hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Tactical tourniquet set up, Medical ultrasound and Questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2021to 14 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Student of the Military Health School of Lyon Bron (Ecoles Militaires de Santé de Lyon Bron; EMSLB);
- Periodic medical examination up to date with the mention "fitness for duty";
- Holder of the "Combat Rescue Level 1" training.
Who cannot join
- Vascular pathology;
- Current progressive pathology of any kind;
- History of thrombo-embolic disease;
- Presence of cardiovascular risk factors (diabetes, hypertension, dyslipidemia, smoking > 1 cigarette/day, BMI > 25);
- Iliofemoral and axillary vascular abnormalities detected by systematic Doppler ultrasound;
- Presence of symptoms suggestive of COVID-19;
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- Positive COVID-19 antigen test;
- In contact with a person diagnosed positive for COVID-19 within 15 days prior to inclusion;
- Pregnant or breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
About this study
Bleeding remains the leading cause of death in combat, and the literature suggests that tourniquetable hemorrhage is the second leading cause of preventable death, behind non- tourniquetable hemorrhage.
Currently, most Western armed forces recommend the use of the tactical tourniquet in combat for the management of tourniquetable hemorrhage.
Read more
The SOFTT® tourniquet (Tactical Medical Solutions, Anderson) is the tactical tourniquet currently in use by the French armed forces. As the contract will soon come to an end, the question of its renewal arises.
The purpose of this study is to compare 4 commercially available tactical tourniquets in healthy volunteers.
The hypothesis of the research is that one of the 4 tourniquets compared is faster to set up than the others.
- Conditions
- Hemorrhage
- Being tested
- Tactical tourniquet set up, Medical ultrasound, Questionnaire
- Keywords
- Tactical tourniquet
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactical tourniquet set upDevice
The tactical tourniquet will be set up to the upper limb and the lower limb during a maximum of 2 minutes.
Medical ultrasoundDiagnostic test
The efficacy of tactical tourniquet set up will be assessed by medical ultrasound.
QuestionnaireOther
The participants will have to fill a questionnaire assessing pain (for the "receiver"), ease of use, stability and rusticity (for the "fitter").
| Study group | Role | What they receive |
|---|---|---|
| SOFTT® Gen 4 tactical tourniquet | Active comparator | The SOFTT® Gen 4 (Tactical Medical Solutions, Anderson) tactical tourniquet will be assessed. Receives: Device: Tactical tourniquet set up; Diagnostic Test: Medical ultrasound; Other: Questionnaire |
| CAT® Gen 7 tactical tourniquet | Active comparator | The CAT® Gen 7 (C-A-T® Resources, Rock Hill) tactical tourniquet will be assessed. Receives: Device: Tactical tourniquet set up; Diagnostic Test: Medical ultrasound; Other: Questionnaire |
| SAM XT® tactical tourniquet | Active comparator | The SAM XT® (SAM Medical Products®, Wilsonville) tactical tourniquet will be assessed. Receives: Device: Tactical tourniquet set up; Diagnostic Test: Medical ultrasound; Other: Questionnaire |
| RMT® 1.5 tactical tourniquet | Active comparator | The RMT® 1.5 (m2®, Winooski) tactical tourniquet will be assessed. Receives: Device: Tactical tourniquet set up; Diagnostic Test: Medical ultrasound; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to apply the tactical tourniquet.
The tourniquet application time, in seconds, measured with a stopwatch. The stopwatch will be started when the fitter takes the tourniquet, pre-positioned in a tourniquet pouch on his bullet vest.
The stopwatch will be stopped as soon as at least one of the following conditions is verified
- the fitter judges the fitting to be effective
- the fitter cannot tighten any more (technical limit)
- the tourniquet is too painful for the receiver.
Measured: Each day during 4 consecutive days
Secondary outcomes (5)
Occlusion of the downstream arterial flow following after tactical tourniquet application
The occlusion of the downstream arterial flow will be assessed by medical ultrasound after tactical tourniquet application
Measured: Each day during 4 consecutive days
Ease of use of the tactical tourniquet
The ease of use of the tactical tourniquet will be measured via a 5-point scale: "very easy", "easy", "intermediate", "hard" and "very hard".
Measured: Each day during 4 consecutive days
Rusticity of the tactical tourniquet
The rusticity of the tactical tourniquet will be assessed via a questionnaire: "sufficiently rustic" or "not sufficiently rustic"
Measured: Each day during 4 consecutive days
Stability of the tactical tourniquet
The stability of the tactical tourniquet will be assessed via a questionnaire, on a 5-point scale: "unstable", "not very stable", "moderately stable", "stable" or "extremely stable".
Measured: Each day during 4 consecutive days
Pain experienced by the receiver during application of the tactical tourniquet
Pain experienced by the receiver during application of the tactical tourniquet, measured by a scale ranging from 0 (no pain) to 10 (most unbearable pain).
Measured: Each day during 4 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start28 May 2021
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All the participants will test the 4 tourniquets (1 tourniquet model = 1 arm) both as a "fitter" (the person who set up the tourniquet) and as a "receiver" (the person on whom the tourniquet is applied).
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870814
- Sponsor's protocol ID
- 2020PPRC05
- Other IDs
- 2021-A00049-32
- Status last verified
- Jul 2021
- First submitted
- 29 Apr 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 4 Tactical Tourniquets Used in War Medicine
- ClinicalTrials.gov ID
- NCT04870814
- Acronym / sponsor ID
- 2020PPRC05
- Conditions
- Hemorrhage
- Keywords
- Tactical tourniquet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bleeding remains the leading cause of death in combat, and the literature suggests that tourniquetable hemorrhage is the second leading cause of preventable death, behind non- tourniquetable hemorrhage.
Currently, most Western armed forces recommend the use of the tactical tourniquet in combat for the management of tourniquetable hemorrhage.
The SOFTT® tourniquet (Tactical Medical Solutions, Anderson) is the tactical tourniquet currently in use by the French armed forces. As the contract will soon come to an end, the question of its renewal arises.
The purpose of this study is to compare 4 commercially available tactical tourniquets in healthy volunteers.
The hypothesis of the research is that one of the 4 tourniquets compared is faster to set up than the others.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All the participants will test the 4 tourniquets (1 tourniquet model = 1 arm) both as a "fitter" (the person who set up the tourniquet) and as a "receiver" (the person on whom the tourniquet is applied).
| Arm | Type | Receives |
|---|---|---|
| SOFTT® Gen 4 tactical tourniquet | Active comparator | Device: Tactical tourniquet set up, Diagnostic Test: Medical ultrasound, Other: QuestionnaireThe SOFTT® Gen 4 (Tactical Medical Solutions, Anderson) tactical tourniquet will be assessed. |
| CAT® Gen 7 tactical tourniquet | Active comparator | Device: Tactical tourniquet set up, Diagnostic Test: Medical ultrasound, Other: QuestionnaireThe CAT® Gen 7 (C-A-T® Resources, Rock Hill) tactical tourniquet will be assessed. |
| SAM XT® tactical tourniquet | Active comparator | Device: Tactical tourniquet set up, Diagnostic Test: Medical ultrasound, Other: QuestionnaireThe SAM XT® (SAM Medical Products®, Wilsonville) tactical tourniquet will be assessed. |
| RMT® 1.5 tactical tourniquet | Active comparator | Device: Tactical tourniquet set up, Diagnostic Test: Medical ultrasound, Other: QuestionnaireThe RMT® 1.5 (m2®, Winooski) tactical tourniquet will be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Student of the Military Health School of Lyon Bron (Ecoles Militaires de Santé de Lyon Bron; EMSLB);
- Periodic medical examination up to date with the mention "fitness for duty";
- Holder of the "Combat Rescue Level 1" training.
Key exclusion criteria (9 listed)
- Vascular pathology;
- Current progressive pathology of any kind;
- History of thrombo-embolic disease;
- Presence of cardiovascular risk factors (diabetes, hypertension, dyslipidemia, smoking > 1 cigarette/day, BMI > 25);
- Iliofemoral and axillary vascular abnormalities detected by systematic Doppler ultrasound;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactical tourniquet set upThe tactical tourniquet will be set up to the upper limb and the lower limb during a maximum of 2 minutes. | Device | CAT® Gen 7 tactical tourniquet, RMT® 1.5 tactical tourniquet, SAM XT® tactical tourniquet, SOFTT® Gen 4 tactical tourniquet |
| Medical ultrasoundThe efficacy of tactical tourniquet set up will be assessed by medical ultrasound. | Diagnostic test | CAT® Gen 7 tactical tourniquet, RMT® 1.5 tactical tourniquet, SAM XT® tactical tourniquet, SOFTT® Gen 4 tactical tourniquet |
| QuestionnaireThe participants will have to fill a questionnaire assessing pain (for the "receiver"), ease of use, stability and rusticity (for the "fitter"). | Other | CAT® Gen 7 tactical tourniquet, RMT® 1.5 tactical tourniquet, SAM XT® tactical tourniquet, SOFTT® Gen 4 tactical tourniquet |
Primary outcome
Time required to apply the tactical tourniquet.
Time frame: Each day during 4 consecutive days
The tourniquet application time, in seconds, measured with a stopwatch. The stopwatch will be started when the fitter takes the tourniquet, pre-positioned in a tourniquet pouch on his bullet vest. The stopwatch will be stopped as soon as at least one of the following conditions is verified * the fitter judges the fitting to be effective * the fitter cannot tighten any more (technical limit) * the tourniquet is too painful for the receiver.
5 secondary outcomes
Occlusion of the downstream arterial flow following after tactical tourniquet application
Time frame: Each day during 4 consecutive days
Ease of use of the tactical tourniquet
Time frame: Each day during 4 consecutive days
Rusticity of the tactical tourniquet
Time frame: Each day during 4 consecutive days
Stability of the tactical tourniquet
Time frame: Each day during 4 consecutive days
Pain experienced by the receiver during application of the tactical tourniquet
Time frame: Each day during 4 consecutive days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactical tourniquet set up, Medical ultrasound and Questionnaire in people with Hemorrhage, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required to apply the tactical tourniquet. (time frame: Each day during 4 consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.