Trial · NCT07900360
Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
NCT07900360, Not applicable, Not yet recruiting, Foundation for Expert Deployment for Governance and Economic Growth (EDGE)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler. Trials, record NCT07900360. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07900360
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
- NCT number
- NCT07900360
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Foundation for Expert Deployment for Governance and Economic Growth (EDGE)
- Conditions
- Hemorrhage, Healthy Volunteers, Arterial Occlusion
- Interventions
- Windlass-type hemostatic tourniquet SICH, Windlass-type hemostatic tourniquet Dnipro, Windlass-type hemostatic tourniquet PULS, Windlass-type hemostatic tourniquet CAT Gen 7 (reference)
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Applications Achieving Complete Arterial Occlusion Confirmed by Blinded Doppler Ultrasound | During each tourniquet application (up to 120 seconds), on Day 1 and Day 3 | 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. |
| Secondary | Time to Complete Arterial Occlusion | During each tourniquet application (up to 120 seconds), Day 1 and Day 3. | 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. |
| Secondary | Pain Intensity on the Visual Analog Scale (VAS) | Day 1 and Day 3: immediately after application, during confirmed occlusion, immediately after device removal, and 30 minutes after removal (4 assessments per period). | 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. |
| Secondary | Subjective Comfort on a 5-Point Likert Scale | 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) | 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. |
| Secondary | Recovery of Distal Arterial Perfusion After Device Removal | Time Frame: Day 1 and Day 3: 1 ± 2 minutes and 30 ± 3 minutes 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. |
| Secondary | Number of Application Attempts | During each tourniquet application, Day 1 and Day 3. | 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. |
| Secondary | Proportion of Applications With Loss of Tension During Exposure | During each tourniquet application, up to 120 seconds, Day 1 and Day 3 | 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. |
| Secondary | Proportion of Applications With Tourniquet Migration | During each tourniquet application, up to 120 seconds, Day 1 and Day 3. | 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. |
| Secondary | Incidence of Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) | 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. | 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. |
| Secondary | Change in Skin Temperature at the Tourniquet Application Site Measured by Infrared Thermometry. | Day 1 and Day 3: immediately before tourniquet application and immediately after device removal. | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07900360
GET https://conductscience.org/api/trials/v1/NCT07900360/registered