NCT01965561

Performance of Junctional Tourniquets in Normal Human Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: United States Army Institute of Surgical Research · Federal
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Hemorrhage

Interventions

Type	Name	Description
DEVICE	CRoC	Use of Combat Ready Clamp (CRoC)
DEVICE	AAJT	Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
DEVICE	JETT	Use of Junctional Emergency Treatment Tool (JETT)
DEVICE	SJT	Use of SAM Junctional Tourniquet (SJT)

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-10-18
• Last updated: 2017-12-13
• Results posted: 2015-10-07

Locations

1 site across 1 country: United States