Blood PressureNCT05324306
Tourniquets Increase Proximal Pressure
A study testing combat application tourniquets (CAT) in people with Blood Pressure, run by Medical University of South Carolina at 1 site in United States.
Trial summary
There is an urgent clinical need to improve survival and neurologic outcomes after cardiac arrest. When a patient goes into cardiac arrest, cardiopulmonary resuscitation (CPR) with chest compressions is the current standard of care treatment to mechanically circulate blood through the patient's body. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- combat application tourniquets (CAT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults with no known chronic medical conditions between the ages of 18 and 60 years old willing and able to consent themselves.
- Subjects who are native English speakers or self-report as fluent in English.
Who cannot join
- Subjects who have a history of or are a current smoker, have a history of or current illicit drug use, have a history of or current alcohol abuse.
- Subjects who self-report as pregnant.
- Subjects who self-report diabetes, cardiac disease including hypertension requiring medication, or a history of compartment syndrome or peripheral vascular disease.
- Subjects with known chronic diseases not listed above, including but not limited to Rheumatoid Arthritis, McArdle's disease, etc.
- Subjects with elevated blood pressure (>130/80mmHg) on the day of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29401
About this study
Official title: Extremity Occlusion With Tourniquets Increases Proximal Systolic Pressure
There is an urgent clinical need to improve survival and neurologic outcomes after cardiac arrest. When a patient goes into cardiac arrest, cardiopulmonary resuscitation (CPR) with chest compressions is the current standard of care treatment to mechanically circulate blood through the patient's body. The immediate and long-term success of CPR is critically dependent on the maintenance of adequate coronary and cerebral perfusion. The investigators propose that CPR outcomes can be improved by capitalizing on the innate mechanism of vasoconstriction and preferentially routing the limited oxygenated blood to the heart and brain. The proposed solution is occlusion of extremity vasculature will increase coronary and cerebral perfusion and improve patient outcomes after cardiac arrest. Prior research has investigated the efficacy of manipulating peripheral vascular resistance with tourniquets in animal studies with improved cardiac and cerebral perfusion and survival. To prove this is an adequate solution in humans, the investigators plan to use tourniquets on the legs to occlude the peripheral vasculature in healthy humans and measure more proximal blood pressure before and after tourniquet deployment. Proof of concept of this solution will make way for development of novel devices for use during cardiac arrest and CPR to improve heart and brain perfusion and ultimately improve cardiac arrest outcomes.
The investigators will recruit 30 healthy human participants and measure their blood pressure in their arm. They will then place two commercially-available, FDA-approved tourniquets around each thigh to stop blood flow to the legs. The investigators will measure the blood pressure in the arms again. They will then release the tourniquets after blood pressure measurement. This will be repeated three times with breaks between each repetition.
- Conditions
- Blood Pressure
- Being tested
- combat application tourniquets (CAT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combat application tourniquets (CAT)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Application of Tourniquets on Lower Extremities | Experimental | 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. Receives: Device: combat application tourniquets (CAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure During Application of the CAT Tourniquets
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Feb 2022
- Primary completion1 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324306
- Sponsor's protocol ID
- 00109291
- Status last verified
- Jul 2024
- First submitted
- 4 Apr 2022
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Seigler SW, Quinn KM, Holman HL, Kim JY, Rajab TK. A single-center, nonblinded, clinical trial comparing blood pressures before and after tourniquet application in healthy humans: A study protocol. PLoS One. 2023 Jan 6;18(1):e0280139. doi: 10.1371/journal.pone.0280139. eCollection 2023.
PubMed 36608001
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extremity Occlusion With Tourniquets Increases Proximal Systolic Pressure
- ClinicalTrials.gov ID
- NCT05324306
- Acronym / sponsor ID
- 00109291
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is an urgent clinical need to improve survival and neurologic outcomes after cardiac arrest. When a patient goes into cardiac arrest, cardiopulmonary resuscitation (CPR) with chest compressions is the current standard of care treatment to mechanically circulate blood through the patient's body. The immediate and long-term success of CPR is critically dependent on the maintenance of adequate coronary and cerebral perfusion. The investigators propose that CPR outcomes can be improved by capitalizing on the innate mechanism of vasoconstriction and preferentially routing the limited oxygenated blood to the heart and brain. The proposed solution is occlusion of extremity vasculature will increase coronary and cerebral perfusion and improve patient outcomes after cardiac arrest. Prior research has investigated the efficacy of manipulating peripheral vascular resistance with tourniquets in animal studies with improved cardiac and cerebral perfusion and survival. To prove this is an adequate solution in humans, the investigators plan to use tourniquets on the legs to occlude the peripheral vasculature in healthy humans and measure more proximal blood pressure before and after tourniquet deployment. Proof of concept of this solution will make way for development of novel devices for use during cardiac arrest and CPR to improve heart and brain perfusion and ultimately improve cardiac arrest outcomes.
The investigators will recruit 30 healthy human participants and measure their blood pressure in their arm. They will then place two commercially-available, FDA-approved tourniquets around each thigh to stop blood flow to the legs. The investigators will measure the blood pressure in the arms again. They will then release the tourniquets after blood pressure measurement. This will be repeated three times with breaks between each repetition.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application of Tourniquets on Lower Extremities | Experimental | Device: combat application tourniquets (CAT)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults with no known chronic medical conditions between the ages of 18 and 60 years old willing and able to consent themselves.
- Subjects who are native English speakers or self-report as fluent in English.
Key exclusion criteria (5 listed)
- Subjects who have a history of or are a current smoker, have a history of or current illicit drug use, have a history of or current alcohol abuse.
- Subjects who self-report as pregnant.
- Subjects who self-report diabetes, cardiac disease including hypertension requiring medication, or a history of compartment syndrome or peripheral vascular disease.
- Subjects with known chronic diseases not listed above, including but not limited to Rheumatoid Arthritis, McArdle's disease, etc.
- Subjects with elevated blood pressure (>130/80mmHg) on the day of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Application of Tourniquets on Lower Extremities |
Primary outcome
Systolic Blood Pressure During Application of the CAT Tourniquets
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36608001Seigler SW, Quinn KM, Holman HL, Kim JY, Rajab TK. A single-center, nonblinded, clinical trial comparing blood pressures before and after tourniquet application in healthy humans: A study protocol. PLoS One. 2023 Jan 6;18(1):e0280139. doi: 10.1371/journal.pone.0280139. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combat application tourniquets (CAT) in people with Blood Pressure, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure During Application of the CAT Tourniquets (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05324306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.