Performance of Junctional Tourniquets in Normal Human Volunteers

Hemorrhage Clinical Trial

Official title:

Performance of Junctional Tourniquets in Normal Human Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965561
• Other study ID #: H-13-016
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2013
• Last updated: November 14, 2017
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2017
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.

Description:

Four FDA-cleared junctional tourniquets (Combat Ready Clamp (CRoC), Abdominal Aortic and Junctional Tourniquet (AAJT), Junctional Emergency Treatment Tool (JETT), and SAM Junctional Tourniquet (SJT)) wereassessed in a laboratory on healthy human volunteers. Lower extremity pulses were measured in 10 volunteers before and after junctional tourniquet application aimed at stopping the distal pulse assessed by Doppler auscultation. Tourniquets were applied in a randomized fashion, with 5 min rest periods between each application. Each tourniquet was applied to each subject, such that the subjects acted as their own controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Device:
• CRoC
Use of Combat Ready Clamp (CRoC)
• AAJT
Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
• JETT
Use of Junctional Emergency Treatment Tool (JETT)
• SJT
Use of SAM Junctional Tourniquet (SJT)

Locations

Country	Name	City	State
United States	United States Army Institute of Surgical Research	Forts Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness at Stopping Distal Pulse	Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.	1 min
Secondary	Pain During Tourniquet Application	Pain during tourniquet application as measured on a visual analog scale (VAS). The pain scale was a 100-mm-long line on a piece of paper. The subject made a cross mark on the line, which went from the left limit (0 mm) at no pain to the right limit (100 mm) at very severe pain.	1 minute