Performance of Junctional Tourniquets in Normal Human Volunteers

• ClinicalTrials.gov Identifier: NCT01965561
• Recruitment Status: Completed
• First Posted: October 18, 2013
• Results First Posted: October 7, 2015
• Last Update Posted: December 13, 2017
• Sponsor: United States Army Institute of Surgical Research
• Information provided by (Responsible Party): John F. Kragh, Jr, MD, United States Army Institute of Surgical Research

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Hemorrhage	Device: CRoC; Device: AAJT; Device: JETT; Device: SJT	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Performance of Junctional Tourniquets in Normal Human Volunteers
• Study Start Date: October 2013
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: CRoC; Use of Combat Ready Clamp (CRoC)	Device: CRoC; Use of Combat Ready Clamp (CRoC)
Experimental: AAJT; Use of Abdominal Aortic and Junctional Tourniquet	Device: AAJT; Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
Experimental: JETT; Junctional Emergency Treatment Tool	Device: JETT; Use of Junctional Emergency Treatment Tool (JETT)
Experimental: SJT; SAM Junctional Tourniquet	Device: SJT; Use of SAM Junctional Tourniquet (SJT)

Outcome Measures

Primary Outcome Measures :

1. Effectiveness at Stopping Distal Pulse [ Time Frame: 1 min ]
   Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.

Secondary Outcome Measures :

1. Pain During Tourniquet Application [ Time Frame: 1 minute ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Texas

United States Army Institute of Surgical Research

Forts Sam Houston, Texas, United States, 78234-7767

Sponsors and Collaborators

United States Army Institute of Surgical Research

Investigators

• Principal Investigator: John F Kragh, MD; United States Army Institute of Surgical Research

More Information

• Responsible Party: John F. Kragh, Jr, MD, Orthopedic Surgeon, Researcher, United States Army Institute of Surgical Research
• ClinicalTrials.gov Identifier: NCT01965561
• Other Study ID Numbers: H-13-016
• First Posted: October 18, 2013
• Results First Posted: October 7, 2015
• Last Update Posted: December 13, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Hemorrhage; Pathologic Processes