An interventional study of Windlass-type hemostatic tourniquet SICH, Windlass-type hemostatic tourniquet Dnipro, Windlass-type hemostatic tourniquet PULS, Windlass-type hemostatic tourniquet CAT Gen 7 (reference) in Hemorrhage, Healthy Volunteers and Arterial Occlusion, sponsored by Foundation for Expert Deployment for Governance and Economic Growth (EDGE). Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Foundation for Expert Deployment for Governance and Economic Growth (EDGE) · Not applicable, Interventional, and Other
The goal of this clinical trial is to learn if three Ukrainian-made windlass tourniquets (SICH, DNIPRO GEN 2 and PULS) stop arterial blood flow in the arm or leg as well as the Combat Application Tourniquet (CAT Gen 7) does. The trial is in healthy adult volunteers, men and women aged 18 to 55 years. Limb tourniquets are used to stop life-threatening bleeding from an arm or leg. The results will support a national standard for windlass tourniquets in Ukraine.
The main question it aims to answer is:
Does each Ukrainian tourniquet completely stop arterial blood flow below the tourniquet within 120 seconds as often as CAT Gen 7? Stopped blood flow will be confirmed by Doppler ultrasound.
Investigators will compare each Ukrainian tourniquet with CAT Gen 7 in the same participant, using one device on the arm and the other on the leg. They will look at whether blood flow is completely stopped and how quickly. They will also compare:
Participants will:
Attend a screening visit with a medical history, physical examination, vital signs, ECG, tests for hepatitis B (HBsAg) and hepatitis C (anti-HCV) on the blood sample, and a rapid HIV test using a mouth swabblood, urine tests including pregnancy test (only for women).
Be randomly assigned to one pair of devices: CAT Gen 7 with SICH, CAT Gen 7 with DNIPRO GEN 2, or CAT Gen 7 with PULS. The order in which the two devices are used will also be chosen at random.
Have a tourniquet applied by trained study staff on two visits at least 24 hours apart. Each time, a different device is used on a different limb (upper arm or thigh), for no longer than 120 seconds.
Have blood flow checked with Doppler ultrasound by a doctor who does not know which device is being used.
Have skin temperature measured, and rate their pain and comfort. Receive follow-up phone calls about 24 hours and 72 hours after the second application. A clinic visit is arranged only if a side effect is reported.
Background Heavy bleeding from an injured arm or leg is one of the main causes of preventable death among people wounded in combat and in serious civilian accidents. A limb tourniquet is a strap placed around the limb above the wound. It is tightened by turning a rigid rod (the "windlass") until blood flow below it stops. International guidelines for combat casualty care (TCCC) recommend applying a windlass tourniquet immediately as the first step to control life-threatening limb bleeding. Wide use of such tourniquets, together with training, has saved many lives.
In Ukraine, several windlass tourniquets are manufactured locally, including SICH, DNIPRO GEN 2 and PULS. They are already widely used by the Armed Forces of Ukraine, alongside internationally recognized devices such as the Combat Application Tourniquet (CAT Gen 7). CAT is the reference tourniquet recommended by the U.S. Committee on Tactical Combat Casualty Care and has the largest body of evidence. Laboratory testing has shown that the Ukrainian tourniquets can stop arterial blood flow. However, they have never been compared directly with CAT in a randomized clinical study with blinded assessment of the result.
This study is therefore designed to:
provide independent, standardized clinical data to support a National Standard of Ukraine for windlass tourniquets.
Study design TORQUE is a prospective, randomized, controlled, open-label clinical investigation with a blinded outcome assessor. It takes place at a single site in Kyiv, Ukraine: the National Institute of Traumatology and Orthopedics of the National Academy of Medical Sciences of Ukraine. It is conducted according to with the principles of the Declaration of Helsinki, ISO 14155:2026 (Good Clinical Practice for medical device studies), and the applicable Ukrainian regulations. It is a non-commercial study. This study is funded by the UK Government through the Foreign, Commonwealth \& Development Office (FCDO), with project implementation support provided by Alinea International Limited in Ukraine. The Acting Sponsor is a Ukrainian public organization "FUND FOR EXPERT SUPPORT OF GOVERNANCE AND ECONOMIC DEVELOPMENT" (EDGE). No medical device manufacturer is involved in the funding, conduct, management, or analysis of the study.
About 120 healthy adult volunteers will take part. They will be randomly assigned in equal numbers (40 each) to one of three device pairs:
CAT Gen 7 and SICH CAT Gen 7 and DNIPRO GEN 2 CAT Gen 7 and PULS
Each participant receives both devices in their pair, one at a time, on two different study days at least 24 hours apart. One device is placed on the upper arm and the other on the thigh, on the same side of the body. The order of the two devices, and which device goes on the arm or the thigh, is also chosen at random. Comparing both devices in the same person reduces the effect of differences between people.
All tourniquets are applied by trained and certified study staff, never by the participants themselves. A thin, standardized protective layer of gauze is placed under each tourniquet to protect the skin. Each application lasts no more than 120 seconds. The tourniquet is released immediately once blood flow is confirmed to be stopped, once 120 seconds have passed, or at any moment the participant asks.
The devices look different, so staff and participants know which device is used. To keep the main result objective, the doctor who checks blood flow with Doppler ultrasound does not know which device is being tested. This doctor sits behind a screen and wears noise-cancelling headphones during application.
What is being measured The main outcome is whether each tourniquet completely stops arterial blood flow below it within 120 seconds of the first turn of the windlass. Complete occlusion means no blood flow signal in the artery of the wrist or foot for at least 10 seconds, confirmed by several Doppler ultrasound methods. The study tests whether each Ukrainian device is not meaningfully worse than CAT Gen 7, defined as no more than 10 percentage points lower in success rate.
Other outcomes include:
A structured record of device faults will be shared with the manufacturers to help improve technical specifications.
What participants will do Screening visit: consent, vital signs,medical history, physical examination, ECG, blood, urine tests, and a pregnancy test for women, tests for hepatitis B (HBsAg) and hepatitis C (anti-HCV) on the blood sample, and a rapid HIV test using a mouth swabblood.
Day 1 and Day 3: a tourniquet is applied once on each day, with ultrasound checks before, during and after application. Participants rate their pain and comfort and stay at the site until normal circulation is confirmed.
Follow-up phone calls: on Day 2, Day 4 and Day 6. An extra clinic visit is arranged only if a side effect is reported.
Total time in the study is about 10 days, from screening to the last phone call.
Safety
Brief tourniquet use in healthy people commonly causes temporary pain, skin marks, redness or numbness. These usually go away quickly. Serious harm is very unlikely with an application time of 120 seconds or less. Measures that reduce risk include:
An independent Data and Safety Monitoring Committee will review safety data, including any serious adverse event. Participants may leave the study at any time without giving a reason.
Who can take part Healthy civilian men and women aged 18 to 55 years with a body mass index of 18.5-29.9 kg/m² can take part. Military personnel, pregnant or breastfeeding women, and people in dependent relationships with the study organizers are not included. This ensures that participation is fully voluntary.
Expected use of results Results will be reported for each device separately. They are intended to be published in a peer-reviewed journal, with no participant identifiable.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's planned enrollment of 120 is above the median of 102 across 926 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →This is the only study on the registry with Foundation for Expert Deployment for Governance and Economic Growth (EDGE) as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the SICH-CAT pair, sequence 1. Period 1 (Day 1): SICH tourniquet (investigational). Period 2 (Day 3): CAT tourniquet (reference). Each device is applied once to the limb by a trained operator using a standardized procedure (maximum 120 seconds to occlusion). Arterial occlusion is assessed by a blinded Doppler ultrasound assessor.
Device: Windlass-type hemostatic tourniquet SICH, Windlass-type hemostatic tourniquet Dnipro, Windlass-type hemostatic tourniquet PULS, Windlass-type hemostatic tourniquet CAT Gen 7 (reference)
Participants randomized to the SICH-CAT pair, sequence 2. Period 1 (Day 1): CAT tourniquet (reference). Period 2 (Day 3): SICH tourniquet (investigational). Application and assessment as in Arm 1.
Device: Windlass-type hemostatic tourniquet SICH, Windlass-type hemostatic tourniquet Dnipro, Windlass-type hemostatic tourniquet PULS, Windlass-type hemostatic tourniquet CAT Gen 7 (reference)
Participants randomized to the Dnipro-CAT pair, sequence 1. Period 1 (Day 1): Dnipro tourniquet (investigational). Period 2 (Day 3): CAT tourniquet (reference). Each device is applied once by a trained operator using a standardized procedure (maximum 120 seconds to occlusion). Arterial occlusion is assessed by a blinded Doppler ultrasound assessor.
Device: Windlass-type hemostatic tourniquet SICH, Windlass-type hemostatic tourniquet Dnipro, Windlass-type hemostatic tourniquet PULS, Windlass-type hemostatic tourniquet CAT Gen 7 (reference)
Participants randomized to the Dnipro-CAT pair, sequence 2. Period 1 (Day 1): CAT tourniquet (reference). Period 2 (Day 3): Dnipro tourniquet (investigational). Application and assessment as in Arm 3.
Device: Windlass-type hemostatic tourniquet SICH, Windlass-type hemostatic tourniquet Dnipro, Windlass-type hemostatic tourniquet PULS, Windlass-type hemostatic tourniquet CAT Gen 7 (reference)
Participants randomized to the PULS-CAT pair, sequence 1. Period 1 (Day 1): PULS tourniquet (investigational). Period 2 (Day 3): CAT tourniquet (reference). Each device is applied once by a trained operator using a standardized procedure (maximum 120 seconds to occlusion). Arterial occlusion is assessed by a blinded Doppler ultrasound assessor.
Device: Windlass-type hemostatic tourniquet SICH, Windlass-type hemostatic tourniquet Dnipro, Windlass-type hemostatic tourniquet PULS, Windlass-type hemostatic tourniquet CAT Gen 7 (reference)
Participants randomized to the PULS-CAT pair, sequence 2. Period 1 (Day 1): CAT tourniquet (reference). Period 2 (Day 3): PULS tourniquet (investigational). Application and assessment as in Arm 5.
Device: Windlass-type hemostatic tourniquet SICH, Windlass-type hemostatic tourniquet Dnipro, Windlass-type hemostatic tourniquet PULS, Windlass-type hemostatic tourniquet CAT Gen 7 (reference)
1. Windlass-type hemostatic tourniquet SICH: applied once by a trained operator to the upper arm or lower thigh; occlusion confirmed by blinded Doppler within 120 s, then released. Compared with CAT Gen 7. 2. Windlass-type hemostatic tourniquet DNIPRO: applied once by a trained operator to the upper arm or lower thigh; occlusion confirmed by blinded Doppler within 120 s, then released. Compared with CAT Gen 7. 3. Windlass-type hemostatic tourniquet PULS: applied once by a trained operator to the upper arm or lower thigh; occlusion confirmed by blinded Doppler within 120 s, then released. Compared with CAT Gen 7. 4. Windlass-type hemostatic tourniquet CAT Gen 7, Reference device: Combat Application Tourniquet Gen 7 (North American Rescue, USA), CE-marked, TCCC-recommended. Applied once by a trained operator using the same standardized procedure; occlusion confirmed by blinded Doppler within 120 s.
Proportion of Applications Achieving Complete Arterial Occlusion Confirmed by Blinded Doppler Ultrasound
Complete distal arterial occlusion is defined as sustained absence of a distal arterial signal for at least 10 consecutive seconds, achieved within 120 seconds of the first windlass turn. It is confirmed by a blinded Doppler assessor using peak systolic/end-diastolic velocity, spectral waveform, color Doppler and handheld Doppler. Each application is scored as achieved or not achieved. The proportion of successful applications is compared between each investigational tourniquet (SICH, Dnipro, PULS) and the CAT Gen 7 reference within the same participants, to test non-inferiority.
Time frame: During each tourniquet application (up to 120 seconds), on Day 1 and Day 3
Time to Complete Arterial Occlusion
Time in seconds from the first windlass turn to complete distal arterial occlusion confirmed by blinded Doppler ultrasound (≥10 consecutive seconds without distal arterial signal). Applications that do not achieve occlusion are right-censored at 120 seconds. Compared within each pair: SICH, Dnipro or PULS vs CAT Gen 7.
Time frame: During each tourniquet application (up to 120 seconds), Day 1 and Day 3.
Pain Intensity on the Visual Analog Scale (VAS)
Participant-rated pain on a 100-mm Visual Analog Scale (0 mm = no pain, 100 mm = worst imaginable pain). Higher scores indicate more pain. Scores are categorized as no pain (0-4 mm), mild (5-44 mm), moderate (45-74 mm) or severe (75-100 mm). They are compared between devices within each pair, and the proportion of applications with severe pain is reported. VAS is a tolerability measure, not an efficacy criterion.
Time frame: Day 1 and Day 3: immediately after application, during confirmed occlusion, immediately after device removal, and 30 minutes after removal (4 assessments per period).
Subjective Comfort on a 5-Point Likert Scale
Participant-rated comfort of the tourniquet application, answered as a single question on a 5-point Likert scale (1 = very uncomfortable, 5 = very comfortable). Higher scores indicate greater comfort. The assessment during occlusion is optional. Compared between devices within each pair.
Time frame: Day 1 and Day 3: immediately after application, during confirmed occlusion (optional), immediately after device removal, and 30 minutes after removal (up to 4 assessments per period)
Recovery of Distal Arterial Perfusion After Device Removal
Distal arterial flow assessed by blinded Doppler ultrasound after the tourniquet is removed. The assessment covers pulsatile signal, peak systolic and end-diastolic velocity, spectral waveform, color Doppler, and handheld Doppler confirmation. Stable reperfusion at 30 minutes is reported as a binary outcome (achieved / not achieved) for each application.
Time frame: Time Frame: Day 1 and Day 3: 1 ± 2 minutes and 30 ± 3 minutes after device removal.
Number of Application Attempts
Number of attempts needed to apply the tourniquet in each application period. It is recorded by the operator or investigator on a structured device-deficiency form at the time of occurrence, as a measure of application reliability.
Time frame: During each tourniquet application, Day 1 and Day 3.
Proportion of Applications With Loss of Tension During Exposure
Proportion of applications in which the tourniquet loses tension during the exposure (occlusion) phase. Recorded by the operator or investigator on a structured device-deficiency form at the time of occurrence, as a measure of application reliability.
Time frame: During each tourniquet application, up to 120 seconds, Day 1 and Day 3
Proportion of Applications With Tourniquet Migration
Proportion of applications in which the tourniquet moves from its original position on the limb during application or exposure. Recorded by the operator or investigator on a structured device-deficiency form at the time of occurrence, as a measure of application reliability.
Time frame: During each tourniquet application, up to 120 seconds, Day 1 and Day 3.
Incidence of Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs)
Number and proportion of participants with adverse device effects (ADEs) and Serious ADEs (SADEs), including unanticipated SADEs (USADEs) defined per MDR (EU) 2017/745, ISO 14155:2026 and MDCG 2020-10/1.
Time frame: From first tourniquet application (Day 1) through end of follow-up: Day 4 (24 hours after Period 2), telephone follow-up, and Day 7 visit if symptomatic.
Change in Skin Temperature at the Tourniquet Application Site Measured by Infrared Thermometry.
Skin surface temperature (°C, recorded to 0.1 °C) at the tourniquet application site, measured with a calibrated non-contact infrared thermometer at a spot marked on the skin at baseline. Measurement conditions are standardized: at least 10-15 minutes of rest with the limb uncovered, room temperature kept within 20-25 °C and recorded at each measurement, and the same device held perpendicular to dry skin at the manufacturer-specified distance. The change is calculated as post-removal minus pre-application temperature and compared between devices within each pair (SICH, Dnipro or PULS vs CAT Gen 7). This is a supportive safety and perfusion measure, not an efficacy criterion.
Time frame: Day 1 and Day 3: immediately before tourniquet application and immediately after device removal.
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