Phase 4
N=10
Performance of Junctional Tourniquets in Normal Human Volunteers
Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT01965561 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Effectiveness at Stopping Distal Pulse — 97; 27; 83; 93 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- CRoC (Device); AAJT (Device); JETT (Device); SJT (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- United States Army Institute of Surgical Research
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness at Stopping Distal Pulse |
97; 27; 83; 93 | — |
| SECONDARY Pain During Tourniquet Application |
30; 76; 45; 43 | — |
Summary
Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.
Eligibility Criteria
Inclusion Criteria
- Adult human volunteers who are recruited, screened, and consent to participate
- Ages at least 18 years old to no more than 60 years old (<61) on the date of consent
- Male or female
- A worker for the US Military or US Government (active duty military, civilian employees, contractors)
Exclusion Criteria
- Active-duty military subjects without their supervisor's permission to participate
- Detainees or prisoners
- Evidence of major disease of an artery (e.g., artery or vein surgery, atherosclerotic disease diagnosis, stroke, peripheral vascular disease or dysfunction such as Reynaud's phenomenon, migraine headaches, or cardiovascular disease [uncontrolled hypertension, heart attack, or arrhythmias]), active abdominal, inguinal, gluteal, or thigh disease, major deformity, or hernias
- Pregnancy
- Contracted employees to the US Military or US Government without contractual permission to participate in the research
Data sourced from ClinicalTrials.gov (NCT01965561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.