Trial Outcomes & Findings for Performance of Junctional Tourniquets in Normal Human Volunteers (NCT NCT01965561)

Results Overview

Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

1 min

Results posted on

2017-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Junctional Tourniquet Use Junctional tourniquet use followed by rest, repeat. Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is a bladder within a belt. CRC is a vice.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance of Junctional Tourniquets in Normal Human Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Junctional Tourniquet Use n=10 Participants Junctional tourniquet use followed by rest, repeat Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is an bladder within a belt. CRC is a vice.
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Pain	0 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 1 min

Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.

Outcome measures

Outcome measures
Measure	CRoC n=10 Participants Use of Combat Ready Clamp (CRoC)	AAJT n=10 Participants Use of Abdominal Aortic and Junctional Tourniquet (AAJT)	JETT n=10 Participants Use of Junctional Emergency Treatment Tool (JETT)	SJT Tourniquet n=10 Participants SAM Junctional Tourniquet (SJT)
Effectiveness at Stopping Distal Pulse	97 percentage of participants	27 percentage of participants	83 percentage of participants	93 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CRoC n=10 Participants Use of Combat Ready Clamp (CRoC)	AAJT n=10 Participants Use of Abdominal Aortic and Junctional Tourniquet (AAJT)	JETT n=10 Participants Use of Junctional Emergency Treatment Tool (JETT)	SJT Tourniquet n=10 Participants SAM Junctional Tourniquet (SJT)
Pain During Tourniquet Application	30 mm on VAS Standard Deviation 23	76 mm on VAS Standard Deviation 14	45 mm on VAS Standard Deviation 40	43 mm on VAS Standard Deviation 31

Adverse Events

Junctional Tourniquet Use

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Kragh, MD

USAISR

Phone: 210.539.2210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place