Trial Outcomes & Findings for Tourniquets Increase Proximal Pressure (NCT NCT05324306)

Results Overview

We define the primary study endpoint as successful application of CAT tourniquets in normal physiology in healthy humans with a minimum increase in blood pressure of 10 mmHg measured in the arms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

the average of 3 repetitions is reported; the duration of each tourniquet application was 5 minutes and participants rested 3-5 minutes between each repetition

Results posted on

2024-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Application of Tourniquets on Lower Extremities Participants will have their baseline blood pressure measured in their upper extremities followed by application of CAT tourniquets to both lower extremities. Blood pressure will be measured again in the upper extremities once the CAT tourniquets are deployed. This will be repeated 3 times. combat application tourniquets (CAT): CAT tourniquets have been indicated for use in emergency situations revolving around a wounded limb, such as hemorrhage control.22-23 CAT tourniquets are the official tourniquet of the US Army since in 2005. We will deploy well-studied and FDA approved combat application tourniquets (CAT) on both thighs of volunteer healthy adult subjects while measuring blood pressure in the upper extremities.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Application of Tourniquets on Lower Extremities n=27 Participants Participants will have their baseline blood pressure measured in their upper extremities followed by application of CAT tourniquets to both lower extremities. Blood pressure will be measured again in the upper extremities once the CAT tourniquets are deployed. This will be repeated 3 times. combat application tourniquets (CAT): CAT tourniquets have been indicated for use in emergency situations revolving around a wounded limb, such as hemorrhage control.22-23 CAT tourniquets are the official tourniquet of the US Army since in 2005. We will deploy well-studied and FDA approved combat application tourniquets (CAT) on both thighs of volunteer healthy adult subjects while measuring blood pressure in the upper extremities.
Age, Continuous	25.74 years n=27 Participants
Sex: Female, Male Female	9 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=27 Participants
Region of Enrollment United States	27 participants n=27 Participants
Systolic Blood Pressure	122 mmHg n=27 Participants
Diastolic Blood Pressure	72 mmHg n=27 Participants
Heart Rate	70 bpm n=27 Participants

PRIMARY outcome

Timeframe: the average of 3 repetitions is reported; the duration of each tourniquet application was 5 minutes and participants rested 3-5 minutes between each repetition

We define the primary study endpoint as successful application of CAT tourniquets in normal physiology in healthy humans with a minimum increase in blood pressure of 10 mmHg measured in the arms.

Outcome measures

Outcome measures
Measure	Application of Tourniquets on Lower Extremities n=27 Participants Participants will have their baseline blood pressure measured in their upper extremities followed by application of CAT tourniquets to both lower extremities. Blood pressure will be measured again in the upper extremities once the CAT tourniquets are deployed. This will be repeated 3 times. combat application tourniquets (CAT): CAT tourniquets have been indicated for use in emergency situations revolving around a wounded limb, such as hemorrhage control.22-23 CAT tourniquets are the official tourniquet of the US Army since in 2005. We will deploy well-studied and FDA approved combat application tourniquets (CAT) on both thighs of volunteer healthy adult subjects while measuring blood pressure in the upper extremities.
Systolic Blood Pressure During Application of the CAT Tourniquets Systolic Blood Pressure	129 mmHg Interval 120.0 to 138.0
Systolic Blood Pressure During Application of the CAT Tourniquets Diastolic Blood Pressure	76 mmHg Interval 69.0 to 83.0

Adverse Events

Application of Tourniquets on Lower Extremities

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

Dr. Konrad Rajab

Medical University of South Carolina

Phone: 843-792-1414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place