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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.
Conditions: Hemorrhage, Healthy Volunteers, Arterial Occlusion
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 120
Sponsor: Foundation for Expert Deployment for Governance and Economic Growth (EDGE)
Summary
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:
* pain and comfort during and after use;
* how fast normal blood flow returns after the tourniquet is removed;
* how reliably each device can be applied;
* any device problems and side effects.
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.
Eligibility Criteria
Inclusion Criteria:
* Men and women aged 18-55 years.
* Absence of vascular, neurological, endocrine, or rheumatological disease.
* Absence of coagulopathies.
* Written informed consent.
* Body mass index (BMI) 18.5-29.9 kg/m².
* Have all four limbs (both upper and lower limbs).
Exclusion Criteria:
* Any diagnosed disease of the arterial or venous system affecting vessel patency, vessel-wall integrity, or limb hemodynamics.
* Chronic or acute somatic disease in a progressive or decompensated state.
* History of any confirmed thrombotic or thromboembolic event, regardless of the type of event and its location.
* Sensory impairment of the limbs, or neurological impairment of limb sensory or motor function.
* Current anticoagulant or antiplatelet therapy.
* Musculoskeletal disease or injury compromising safe tourniquet application or gait testing.
* Concurrent participation in another clinical investigation.
* History of organ transplantation.
* Cognitive impairment precluding informed consent or protocol compliance.
* Any hematological (blood) disease.
* Use of hormonal or immunosuppressive medication.
* Active systemic or local infection.
* History of malignancy, or a currently diagnosed neoplastic process in any organ or tissue.
* History of myocardial infarction or stroke.
* Renal or hepatic insufficiency.
* Chromosomal disease.
* Peripheral nervous system disease.
* Pregnancy, suspected pregnancy, or lactation (women of childbearing potential).
* Low pain threshold
* Any other condition that, in the investigator's judgment, may increase risk or confound interpretation of results.
Source: ClinicalTrials.gov (NCT07900360). StuddyBuddy aggregates publicly available trial information.