HemorrhageGARROTSNCT03218176
Tourniquets Type Combat Application Tourniquet: Proximal or Distal Location, Simple or Staggered on Upper and Lower Limb
A study testing Proximal single upper limb, Proximal staggered upper limb and Distal single upper limb in people with Hemorrhage, run by University Hospital, Brest at 1 site in France.
Trial summary
A tourniquet is used to stop abundant bleeding when simple compression is not effective. The investigators will study the vascular suffering of the tourniquets according to their location on the limb: limb (arm / thigh) or distal (forearm / leg). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Proximal single upper limb, Proximal staggered upper limb and Distal single upper limb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2017to 23 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years (major)
- Volunteer to participate in research
Who cannot join
- Age less than 18 years
- Known coagulation disorder
- Known vascular disorder
- Known neurological disorder of the limbs
- Known muscle disorders of the limbs
- Presence of an implant in one of the limbs (vascular, contraceptive ...)
Show all 10Show fewer
- Simultaneous participation in research involving anticoagulant therapy
- History of phlebitis
- Persons of full age who are subject to legal protection (safeguard of justice, person placed in curatorship, guardianship), persons deprived of their liberty.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tourniquets Type Combat Application Tourniquet (CAT): Vascular Suffering According to the Proximal or Distal Location, Simple or Staggered. Study to Upper and Lower Limbs
A tourniquet is used to stop abundant bleeding when simple compression is not effective. The investigators will study the vascular suffering of the tourniquets according to their location on the limb: limb (arm / thigh) or distal (forearm / leg). Vascular suffering will be evaluated by the loss of the radial doppler flux for the tourniquets placed on the upper limb and in the tibial anterior to the lower limb by the loss of the pulse oximetry pulse and the collection of the signs described by the volunteers (pain, Paresthesia, cold sensation).
- Conditions
- Hemorrhage
- Being tested
- Proximal single upper limb, Proximal staggered upper limb, Distal single upper limb, Distal staggered upper limb, Proximal single lower limb
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal single upper limbDevice
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Proximal staggered upper limbDevice
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Distal single upper limbDevice
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Distal staggered upper limbDevice
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Proximal single lower limbDevice
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Proximal staggered lower limbDevice
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Distal single lower limbDevice
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Distal staggered lower limbDevice
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
| Study group | Role | What they receive |
|---|---|---|
| Proximal single upper limb | Active comparator | Laying a single tourniquet on the root of the upper limb Receives: Device: Proximal single upper limb |
| Proximal staggered upper limb | Experimental | Laying two staggered tourniquets : one on the root of the upper limb and a second 5 cm below the previous one Receives: Device: Proximal staggered upper limb |
| Distal single upper limb | Experimental | Laying a single tourniquet on the forearm Receives: Device: Distal single upper limb |
| Distal staggered upper limb | Experimental | Laying two staggered tourniquets : one on the forearm and a second 5 cm below the previous one Receives: Device: Distal staggered upper limb |
| Proximal single lower limb | Active comparator | Laying a single tourniquet on the root of the lower limb Receives: Device: Proximal single lower limb |
| Proximal staggered lower limb | Experimental | Laying two staggered tourniquets : one on the root of the lower limb and a second 5 cm below the previous one Receives: Device: Proximal staggered lower limb |
| Distal single lower limb | Experimental | Laying a single tourniquet on the calf Receives: Device: Distal single lower limb |
| Distal staggered lower limb | Experimental | Laying two staggered tourniquets : one on the calf and a second 5 cm below the previous one Receives: Device: Distal staggered lower limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb : Assessment of Pain by Digital Evaluation (EN) after 10 min of compression
The main evaluation criterion for the superior member is the assessment of the pain felt according to the location of the tourniquets at the time of laying and at 10min. For the same location of tourniquet, the pain caused by the laying of one versus two tourniquets will be compared. For proximal versus distal, comparisons will be made for 1 tourniquet and for staggered tourniquets.
Measured: 10 min
Lower limb : Pressure (mmHg) needed to abolish the pulse
The main evaluation criterion for the inferior member is the pressure under the tourniquet, necessary to obtain an abolition of the anterior tibial pulse (measured in Doppler). By means of a balloon connected to a pressure gauge and fixed under each tourniquet, a measure of the pressure exerted (in mmHg) by the tourniquet (s) on the skin will be measured at laying. The comparison will be made for each type of pose (single vs stage) between the proximal and distal layers.
Measured: 10 min
Secondary outcomes (4)
Lower limb pain
The pain will be relieved according to the Digital Scale at the time of the raising of the tourniquets and at 10 minutes. For the same location of tourniquet, the pain caused by the laying of one versus two tourniquets will be compared. For proximal versus distal, comparisons will be made for 1 tourniquet and for staggered tourniquets.
Measured: 10 min
Upper limb pressure under tourniquet
By means of a balloon connected to a pressure gauge and fixed under each tourniquet, a measure of the pressure exerted (in mmHg) by the tourniquet (s) on the skin will be measured at laying. The comparison will be made for each type of pose (single vs staggered) between the proximal and distal layers.
Measured: 10 min
Pulse oximetry
Evaluation of the loss of the pulse oximetry, by a pulse oximeter placed on the finger or the toe, according to each mode of pose
Measured: 10 min
Loss of arterial Doppler pulse
The loss of the Doppler signal on the radial artery for the upper limbs and on the tibial anterior artery for the lower limbs will be evaluated for each type of poses to confirm arterial occlusion for each type of pose.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start31 Jul 2017
- Primary completion23 Oct 2017
- Study completion23 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Gelin, MD, Principal investigator, CHU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218176
- Sponsor's protocol ID
- GARROTS (29BRC17.0087)
- Acronym
- GARROTS
- Status last verified
- Oct 2017
- First submitted
- 10 Jul 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tourniquets Type Combat Application Tourniquet (CAT): Vascular Suffering According to the Proximal or Distal Location, Simple or Staggered. Study to Upper and Lower Limbs
- ClinicalTrials.gov ID
- NCT03218176
- Acronym / sponsor ID
- GARROTS / GARROTS (29BRC17.0087)
- Conditions
- Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A tourniquet is used to stop abundant bleeding when simple compression is not effective. The investigators will study the vascular suffering of the tourniquets according to their location on the limb: limb (arm / thigh) or distal (forearm / leg). Vascular suffering will be evaluated by the loss of the radial doppler flux for the tourniquets placed on the upper limb and in the tibial anterior to the lower limb by the loss of the pulse oximetry pulse and the collection of the signs described by the volunteers (pain, Paresthesia, cold sensation).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Proximal single upper limb | Active comparator | Device: Proximal single upper limbLaying a single tourniquet on the root of the upper limb |
| Proximal staggered upper limb | Experimental | Device: Proximal staggered upper limbLaying two staggered tourniquets : one on the root of the upper limb and a second 5 cm below the previous one |
| Distal single upper limb | Experimental | Device: Distal single upper limbLaying a single tourniquet on the forearm |
| Distal staggered upper limb | Experimental | Device: Distal staggered upper limbLaying two staggered tourniquets : one on the forearm and a second 5 cm below the previous one |
| Proximal single lower limb | Active comparator | Device: Proximal single lower limbLaying a single tourniquet on the root of the lower limb |
| Proximal staggered lower limb | Experimental | Device: Proximal staggered lower limbLaying two staggered tourniquets : one on the root of the lower limb and a second 5 cm below the previous one |
| Distal single lower limb | Experimental | Device: Distal single lower limbLaying a single tourniquet on the calf |
| Distal staggered lower limb | Experimental | Device: Distal staggered lower limbLaying two staggered tourniquets : one on the calf and a second 5 cm below the previous one |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years (major)
- Volunteer to participate in research
Key exclusion criteria (10 listed)
- Age less than 18 years
- Known coagulation disorder
- Known vascular disorder
- Known neurological disorder of the limbs
- Known muscle disorders of the limbs
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 |
|---|---|---|
| Proximal single upper limbMeasurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry | Device | Proximal single upper limb |
| Proximal staggered upper limbMeasurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry | Device | Proximal staggered upper limb |
| Distal single upper limbMeasurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry | Device | Distal single upper limb |
| Distal staggered upper limbMeasurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry | Device | Distal staggered upper limb |
| Proximal single lower limbMeasurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry | Device | Proximal single lower limb |
| Proximal staggered lower limbMeasurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry | Device | Proximal staggered lower limb |
| Distal single lower limbMeasurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry | Device | Distal single lower limb |
| Distal staggered lower limbMeasurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry | Device | Distal staggered lower limb |
Primary outcome
Upper limb : Assessment of Pain by Digital Evaluation (EN) after 10 min of compression
Time frame: 10 min
The main evaluation criterion for the superior member is the assessment of the pain felt according to the location of the tourniquets at the time of laying and at 10min. For the same location of tourniquet, the pain caused by the laying of one versus two tourniquets will be compared. For proximal versus distal, comparisons will be made for 1 tourniquet and for staggered tourniquets.
Lower limb : Pressure (mmHg) needed to abolish the pulse
Time frame: 10 min
The main evaluation criterion for the inferior member is the pressure under the tourniquet, necessary to obtain an abolition of the anterior tibial pulse (measured in Doppler). By means of a balloon connected to a pressure gauge and fixed under each tourniquet, a measure of the pressure exerted (in mmHg) by the tourniquet (s) on the skin will be measured at laying. The comparison will be made for each type of pose (single vs stage) between the proximal and distal layers.
4 secondary outcomes
Lower limb pain
Time frame: 10 min
Upper limb pressure under tourniquet
Time frame: 10 min
Pulse oximetry
Time frame: 10 min
Loss of arterial Doppler pulse
Time frame: 10 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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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.
Emilie Gelin, MD principal investigator
CHU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal single upper limb, Proximal staggered upper limb and Distal single upper limb in people with Hemorrhage, run by University Hospital, Brest at 1 site in France.
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 10 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 1 Nov 2017. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Upper limb : Assessment of Pain by Digital Evaluation (EN) after 10 min of compression (time frame: 10 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2017.