HemorrhageNCT02592655
A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet
A study testing Pneumatic Tourniquet, One Windlass Tourniquet and Two Windlass Tourniquets in people with Hemorrhage and Vascular Injury, run by Marcus Migura at 1 site in United States.
Trial summary
This cross-over study of twenty five (anticipated) healthy human subjects will utilize two active control devices, and two different widths of the investigational device. One active control is representative of the usual care tourniquet applied in hospital settings. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage, Vascular Injury
- What is being tested?
- Pneumatic Tourniquet, One Windlass Tourniquet and Two Windlass Tourniquets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Upper thigh circumference greater than 61 cm or 24 inches.
- Upper thigh circumference greater than the 50th percentile based on available anthropometric data.
Who cannot join
- Currently taking medications for the treatment of hypertension.
- Cardiac, renal, pulmonary, hepatic or hemologic disease or disorder.
- Patients with signs or symptoms of vascular insufficiency. Specifically, patients with any history of non-healing wound, ulcer, blood clots or peripheral vascular disease will be excluded.
- Any coagulation disorder, prior thrombotic or embolic events such as a deep vein thrombosis.
- Sickle cell.
- Diabetes mellitus
Show all 13Show fewer
- Rheumatic arthritis or other auto immune disease.
- Major surgery, significant traumatic injury, within 60 days trial.
- Skin grafts on lower extremities.
- Known or observed neurological symptoms, to include peripheral neurological symptoms or deficits.
- Pregnant women, and women who suspect themselves to be pregnant are not eligible for this study.
- Any known malignancy.
- Claudication
Trial locations and contacts
1 site in 1 country.
United States1 site
Vascular Medicine & Surgical Associates
Youngstown, Ohio, 44501
About this study
Official title: Randomized Sequence, Assessor-Blind, Cross-Over Study of a Windlass Tourniquet, a Pneumatic Tourniquet and an Elastic Adhesive Bandage for Use as a Tourniquet
This cross-over study of twenty five (anticipated) healthy human subjects will utilize two active control devices, and two different widths of the investigational device. One active control is representative of the usual care tourniquet applied in hospital settings. The second active control is a windlass tourniquet representative of the pre-hospital and military usual care tourniquet device. Two inch and four inch widths of the investigational device will be evaluated. The purpose of this study is to characterize and compare investigational and control tourniquet safety and efficacy. All tourniquets will be applied to the upper thigh. Efficacy data is provided by the presence or absence of popliteal flow when assessed with ultrasound. Mapping of interface pressures between the skin and the tourniquet will provide safety data. A minimum washout of five minutes will be allowed between tourniquet applications. All interventions will be applied in one visit. No follow up visit is anticipated.
Read the detailed description
This is a small study of 19 participants conducted over only two days. All data for this study is collected by the study.
Tourniquet application:
All tourniquet applications conducted with the participant seated on the edge of an exam table with one leg hanging off the side, and the leg for tourniquet application extended outward, with the mid calf resting on a support. This position permits access to the popliteal artery for ultrasonography while the investigator has access to apply the tourniquet. The lower edge of each tourniquet is aligned just above the middle of the thigh. All tourniquets are applied over the pressure mapping sensor. The sensor is slightly thicker than denim jeans. Extra care must be taken to ensure that the material of the sensor does not interfere with removing the slack from the windlass tourniquets before turning the windlass to apply final pressure.
When a second windlass tourniquet is to be applied it is applied just above or proximal to the first windlass tourniquet. The windlass of each tourniquet are located as far from each other as possible. Meaning that if the windlass of the first tourniquet is the twelve o'clock position then the windlass of the second tourniquet is positioned at the six o'clock position. The strap of each tourniquet cannot slip over the windlass of the other. This 6 and 12 positioning prevents the strap of the second windlass tourniquet from slipping over the first as it is tightened.
When the tape tourniquet is applied, it is elongated, stretched as it is layered over the preceding layer with at least one half over lap. The tape tourniquet used in this study is similar to, but not the same as the product called manufactured by Entrotech, called "Battle Wrap." Results similar to this study should not be expected with the "Battle Wrap" product.
- Conditions
- Hemorrhage, Vascular Injury
- Being tested
- Pneumatic Tourniquet, One Windlass Tourniquet, Two Windlass Tourniquets, Tourniquet Tape 5 cm, Tourniquet Tape 10 cm
- Keywords
- tourniquet, arterial, pre-hospital, SOFTT-W, Battle Wrap, windlass, exsanguination, hemorrhage, amputation
- Medical subject headings
- Hemorrhage, Vascular System Injuries, Exsanguination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic TourniquetDevice
Also called Zimmer Automatic Tourniquet System (ATS) 1500
Automated pneumatic tourniquet, applied to middle upper thigh.
One Windlass TourniquetDevice
Also called Special Operations Forces Tactical Tourniquet Wide (SOFTT-W)
One Windlass Tourniquet 3.8 cm (1.5 inch) wide. A Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) will be used for the windlass tourniquet. One windlass tourniquet will be applied to the middle upper thigh.
Two Windlass TourniquetsDevice
Two Windlass Tourniquets will be applied by applying a second 3.8 cm (1.5 inch) wide windlass tourniquet immediately proximal to the first windlass tourniquet.
Tourniquet Tape 5 cmDevice
Tourniquet Tape is 5 cm (2 inch) in width. Tourniquet Tape is a highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb. The tape should be stretched and overlapped by at least half the width as it is applied. The final wrap should be applied without tension.
Tourniquet Tape 10 cmDevice
Tourniquet Tape is 10 cm (4 inch) in width. Tourniquet Tape is a highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb. The tape should be stretched and overlapped by at least half the width as it is applied. The final wrap should be applied without tension.
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic Tourniquet | Active comparator | All participants randomly allocated to receive all interventions. Pneumatic Tourniquet: The Automatic Tourniquet System (ATS) 1500 by Zimmer (formerly Aspen Labs) is a pneumatic tourniquet that is typically used in surgical settings, and is representative of best outcome under the ideal circumstances of a controlled environment. The 10 cm (4 inch) wide cylindrical cuff was used for all participants. Receives: Device: Pneumatic Tourniquet |
| Windlass Tourniquet | Active comparator | Windlass Tourniquet with a 3.8 cm (1.5 inch) wide strap is representative of the typical use device in civilian prehospital and military combat environments. In accordance with current prehospital guidelines: If distal perfusion is observed after One Windlass Tourniquet is applied then a second windlass tourniquet will be applied immediately proximal to the first windlass tourniquet so that the participant has Two Windlass Tourniquets applied. Receives: Device: One Windlass Tourniquet; Device: Two Windlass Tourniquets |
| Tourniquet Tape 10 cm | Experimental | Tourniquet Tape 10 cm wide is a highly elastic transparent occlusive tape that is expected to create sufficient circumferential pressure to occlude arterial blood flow when tightly wrapped around a limb. The tape should be applied in mostly overlapping layers. The final wrap should be applied without tension to prevent the elastic tension from causing the tape to unwind itself. Receives: Device: Tourniquet Tape 5 cm |
| Tourniquet Tape 5 cm | Experimental | Tourniquet Tape 5 cm wide is a highly elastic transparent occlusive tape that is expected to create sufficient circumferential pressure to occlude arterial blood flow when tightly wrapped around a limb. The tape should be applied in mostly overlapping layers. The final wrap should be applied without tension to prevent the elastic tension from causing the tape to unwind itself. Receives: Device: Tourniquet Tape 10 cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologist Limb Occlusion Assessment
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
The 5 cm tape was discontinued after the 4th participant because the tape was considered to unacceptably narrow after stretching and this was considered a mechanical failure even if occlusion was observed. Therefore the 5 cm tape data was not evaluated by the radiologist.
Measured: For 1 sustained minute after application of each tourniquet intervention.
Investigator Limb Occlusion Assessment
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered a successful occlusion. This assessment was made by the investigator and ultrasonographer applying the intervention.
Measured: For 1 sustained minute after application of each tourniquet intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2015
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 (10)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcus Migura
- Collaborators
- Mercy Health
- Responsible party
- Sponsor-investigator, Marcus Migura, Migura, Marcus
- Investigators
- Marcus W Migura, Principal investigator, Unafiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592655
- Sponsor's protocol ID
- HCT001
- Status last verified
- Jan 2016
- First submitted
- 27 Oct 2015
- Last updated
- 24 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual participant data will be de-identified and consolidated into one Excel file and made available online. Still ultrasound images used for primary outcome assessment will be consolidated into one pdf and made available online. Individual participant data that is not supported by clinicaltrials.gov will be posted with Zenodo or by other means. The intent to release de-identified data was disclosed to each volunteer during the informed consent process.
Publications
Kragh JF Jr, O'Neill ML, Walters TJ, Dubick MA, Baer DG, Wade CE, Holcomb JB, Blackbourne LH. The military emergency tourniquet program's lessons learned with devices and designs. Mil Med. 2011 Oct;176(10):1144-52. doi: 10.7205/milmed-d-11-00114.
PubMed 22128650Wenke JC, Walters TJ, Greydanus DJ, Pusateri AE, Convertino VA. Physiological evaluation of the U.S. Army one-handed tourniquet. Mil Med. 2005 Sep;170(9):776-81. doi: 10.7205/milmed.170.9.776.
PubMed 16261983Taylor DM, Vater GM, Parker PJ. An evaluation of two tourniquet systems for the control of prehospital lower limb hemorrhage. J Trauma. 2011 Sep;71(3):591-5. doi: 10.1097/TA.0b013e31820e0e41.
PubMed 21768905Swan KG Jr, Wright DS, Barbagiovanni SS, Swan BC, Swan KG. Tourniquets revisited. J Trauma. 2009 Mar;66(3):672-5. doi: 10.1097/TA.0b013e3181986959.
PubMed 19276736King RB, Filips D, Blitz S, Logsetty S. Evaluation of possible tourniquet systems for use in the Canadian Forces. J Trauma. 2006 May;60(5):1061-71. doi: 10.1097/01.ta.0000215429.94483.a7.
PubMed 16688072Walters TJ, Mabry RL. Issues related to the use of tourniquets on the battlefield. Mil Med. 2005 Sep;170(9):770-5. doi: 10.7205/milmed.170.9.770.
PubMed 16261982Walters TJ, Wenke JC, Kauvar DS, McManus JG, Holcomb JB, Baer DG. Effectiveness of self-applied tourniquets in human volunteers. Prehosp Emerg Care. 2005 Oct-Dec;9(4):416-22. doi: 10.1080/10903120500255123.
PubMed 16263675Ruterbusch VL, Swiergosz MJ, Montgomery LD, Hopper KW, Gerth WA. (U) ONR/MARCORSYSCOM Evaluation of Self-Applied Tourniquets for Combat Applications. Panama City, FL, US : Navy Experimental Diving Unit, November 10, 2005. NEDU Technical Report No.05-15.
Hill JP, Montgomery LD, Hopper KW, Roy LA. (U) ONR/MARCORSYSCOM Evaluation of Self-Applied Tourniquets for Combat Applications, Second Phase. Panama City, FL, US : Navy Experimental Diving Unit, April 3, 2007. NEDU Technical Report No.07-07.
Thomas J. Walters PhD; Joseph C. Wenke PhD; SFC Dominique; Greydanus, USA; David S. Kauvar MD, CPT, MC; David G. Baer PhD. (U) U. S. Army Institute of Surgical Research Laboratory Evaluation of Battlefield Tourniquets in Human Volunteers, Ft. Sam Houston, TX: U. S. Army Institute of Surgical Research, September 30, 2005. USAISR Technical Report No.2005-05
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Sequence, Assessor-Blind, Cross-Over Study of a Windlass Tourniquet, a Pneumatic Tourniquet and an Elastic Adhesive Bandage for Use as a Tourniquet
- ClinicalTrials.gov ID
- NCT02592655
- Acronym / sponsor ID
- HCT001
- Conditions
- Hemorrhage, Vascular Injury
- Keywords
- tourniquet, arterial, pre-hospital, SOFTT-W, Battle Wrap, windlass, exsanguination, hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Marcus Migura
- Collaborators
- Mercy Health
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Posted 24 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cross-over study of twenty five (anticipated) healthy human subjects will utilize two active control devices, and two different widths of the investigational device. One active control is representative of the usual care tourniquet applied in hospital settings. The second active control is a windlass tourniquet representative of the pre-hospital and military usual care tourniquet device. Two inch and four inch widths of the investigational device will be evaluated. The purpose of this study is to characterize and compare investigational and control tourniquet safety and efficacy. All tourniquets will be applied to the upper thigh. Efficacy data is provided by the presence or absence of popliteal flow when assessed with ultrasound. Mapping of interface pressures between the skin and the tourniquet will provide safety data. A minimum washout of five minutes will be allowed between tourniquet applications. All interventions will be applied in one visit. No follow up visit is anticipated.
Detailed description
This is a small study of 19 participants conducted over only two days. All data for this study is collected by the study.
Tourniquet application:
All tourniquet applications conducted with the participant seated on the edge of an exam table with one leg hanging off the side, and the leg for tourniquet application extended outward, with the mid calf resting on a support. This position permits access to the popliteal artery for ultrasonography while the investigator has access to apply the tourniquet. The lower edge of each tourniquet is aligned just above the middle of the thigh. All tourniquets are applied over the pressure mapping sensor. The sensor is slightly thicker than denim jeans. Extra care must be taken to ensure that the material of the sensor does not interfere with removing the slack from the windlass tourniquets before turning the windlass to apply final pressure.
When a second windlass tourniquet is to be applied it is applied just above or proximal to the first windlass tourniquet. The windlass of each tourniquet are located as far from each other as possible. Meaning that if the windlass of the first tourniquet is the twelve o'clock position then the windlass of the second tourniquet is positioned at the six o'clock position. The strap of each tourniquet cannot slip over the windlass of the other. This 6 and 12 positioning prevents the strap of the second windlass tourniquet from slipping over the first as it is tightened.
When the tape tourniquet is applied, it is elongated, stretched as it is layered over the preceding layer with at least one half over lap. The tape tourniquet used in this study is similar to, but not the same as the product called manufactured by Entrotech, called "Battle Wrap." Results similar to this study should not be expected with the "Battle Wrap" product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pneumatic Tourniquet | Active comparator | Device: Pneumatic TourniquetAll participants randomly allocated to receive all interventions. Pneumatic Tourniquet: The Automatic Tourniquet System (ATS) 1500 by Zimmer (formerly Aspen Labs) is a pneumatic tourniquet that is typically used in surgical settings, and is representative of best outcome under the ideal circumstances of a controlled environment. The 10 cm (4 inch) wide cylindrical cuff was used for all participants. |
| Windlass Tourniquet | Active comparator | Device: One Windlass Tourniquet, Device: Two Windlass TourniquetsWindlass Tourniquet with a 3.8 cm (1.5 inch) wide strap is representative of the typical use device in civilian prehospital and military combat environments. In accordance with current prehospital guidelines: If distal perfusion is observed after One Windlass Tourniquet is applied then a second windlass tourniquet will be applied immediately proximal to the first windlass tourniquet so that the participant has Two Windlass Tourniquets applied. |
| Tourniquet Tape 10 cm | Experimental | Device: Tourniquet Tape 5 cmTourniquet Tape 10 cm wide is a highly elastic transparent occlusive tape that is expected to create sufficient circumferential pressure to occlude arterial blood flow when tightly wrapped around a limb. The tape should be applied in mostly overlapping layers. The final wrap should be applied without tension to prevent the elastic tension from causing the tape to unwind itself. |
| Tourniquet Tape 5 cm | Experimental | Device: Tourniquet Tape 10 cmTourniquet Tape 5 cm wide is a highly elastic transparent occlusive tape that is expected to create sufficient circumferential pressure to occlude arterial blood flow when tightly wrapped around a limb. The tape should be applied in mostly overlapping layers. The final wrap should be applied without tension to prevent the elastic tension from causing the tape to unwind itself. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Upper thigh circumference greater than 61 cm or 24 inches.
- Upper thigh circumference greater than the 50th percentile based on available anthropometric data.
Key exclusion criteria (13 listed)
- Currently taking medications for the treatment of hypertension.
- Cardiac, renal, pulmonary, hepatic or hemologic disease or disorder.
- Patients with signs or symptoms of vascular insufficiency. Specifically, patients with any history of non-healing wound, ulcer, blood clots or peripheral vascular disease will be excluded.
- Any coagulation disorder, prior thrombotic or embolic events such as a deep vein thrombosis.
- Sickle cell.
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 |
|---|---|---|
| Pneumatic TourniquetAlso: Zimmer Automatic Tourniquet System (ATS) 1500Automated pneumatic tourniquet, applied to middle upper thigh. | Device | Pneumatic Tourniquet |
| One Windlass TourniquetAlso: Special Operations Forces Tactical Tourniquet Wide (SOFTT-W)One Windlass Tourniquet 3.8 cm (1.5 inch) wide. A Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) will be used for the windlass tourniquet. One windlass tourniquet will be applied to the middle upper thigh. | Device | Windlass Tourniquet |
| Two Windlass TourniquetsTwo Windlass Tourniquets will be applied by applying a second 3.8 cm (1.5 inch) wide windlass tourniquet immediately proximal to the first windlass tourniquet. | Device | Windlass Tourniquet |
| Tourniquet Tape 5 cmTourniquet Tape is 5 cm (2 inch) in width. Tourniquet Tape is a highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb. The tape should be stretched and overlapped by at least half the width as it is applied. The final wrap should be applied without tension. | Device | Tourniquet Tape 10 cm |
| Tourniquet Tape 10 cmTourniquet Tape is 10 cm (4 inch) in width. Tourniquet Tape is a highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb. The tape should be stretched and overlapped by at least half the width as it is applied. The final wrap should be applied without tension. | Device | Tourniquet Tape 5 cm |
Primary outcome
Radiologist Limb Occlusion Assessment
Time frame: For 1 sustained minute after application of each tourniquet intervention.
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor. The 5 cm tape was discontinued after the 4th participant because the tape was considered to unacceptably narrow after stretching and this was considered a mechanical failure even if occlusion was observed. Therefore the 5 cm tape data was not evaluated by the radiologist.
Investigator Limb Occlusion Assessment
Time frame: For 1 sustained minute after application of each tourniquet intervention.
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered a successful occlusion. This assessment was made by the investigator and ultrasonographer applying the intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22128650Kragh JF Jr, O'Neill ML, Walters TJ, Dubick MA, Baer DG, Wade CE, Holcomb JB, Blackbourne LH. The military emergency tourniquet program's lessons learned with devices and designs. Mil Med. 2011 Oct;176(10):1144-52. doi: 10.7205/milmed-d-11-00114.
- Background: PubMed 16261983Wenke JC, Walters TJ, Greydanus DJ, Pusateri AE, Convertino VA. Physiological evaluation of the U.S. Army one-handed tourniquet. Mil Med. 2005 Sep;170(9):776-81. doi: 10.7205/milmed.170.9.776.
- Background: PubMed 21768905Taylor DM, Vater GM, Parker PJ. An evaluation of two tourniquet systems for the control of prehospital lower limb hemorrhage. J Trauma. 2011 Sep;71(3):591-5. doi: 10.1097/TA.0b013e31820e0e41.
- Background: PubMed 19276736Swan KG Jr, Wright DS, Barbagiovanni SS, Swan BC, Swan KG. Tourniquets revisited. J Trauma. 2009 Mar;66(3):672-5. doi: 10.1097/TA.0b013e3181986959.
- Background: PubMed 16688072King RB, Filips D, Blitz S, Logsetty S. Evaluation of possible tourniquet systems for use in the Canadian Forces. J Trauma. 2006 May;60(5):1061-71. doi: 10.1097/01.ta.0000215429.94483.a7.
- Background: PubMed 16261982Walters TJ, Mabry RL. Issues related to the use of tourniquets on the battlefield. Mil Med. 2005 Sep;170(9):770-5. doi: 10.7205/milmed.170.9.770.
- Background: PubMed 16263675Walters TJ, Wenke JC, Kauvar DS, McManus JG, Holcomb JB, Baer DG. Effectiveness of self-applied tourniquets in human volunteers. Prehosp Emerg Care. 2005 Oct-Dec;9(4):416-22. doi: 10.1080/10903120500255123.
- BackgroundRuterbusch VL, Swiergosz MJ, Montgomery LD, Hopper KW, Gerth WA. (U) ONR/MARCORSYSCOM Evaluation of Self-Applied Tourniquets for Combat Applications. Panama City, FL, US : Navy Experimental Diving Unit, November 10, 2005. NEDU Technical Report No.05-15.
- BackgroundHill JP, Montgomery LD, Hopper KW, Roy LA. (U) ONR/MARCORSYSCOM Evaluation of Self-Applied Tourniquets for Combat Applications, Second Phase. Panama City, FL, US : Navy Experimental Diving Unit, April 3, 2007. NEDU Technical Report No.07-07.
- BackgroundThomas J. Walters PhD; Joseph C. Wenke PhD; SFC Dominique; Greydanus, USA; David S. Kauvar MD, CPT, MC; David G. Baer PhD. (U) U. S. Army Institute of Surgical Research Laboratory Evaluation of Battlefield Tourniquets in Human Volunteers, Ft. Sam Houston, TX: U. S. Army Institute of Surgical Research, September 30, 2005. USAISR Technical Report No.2005-05
- Individual participant dataSharing planned: Yes. Individual participant data will be de-identified and consolidated into one Excel file and made available online. Still ultrasound images used for primary outcome assessment will be consolidated into one pdf and made available online. Individual participant data that is not supported by clinicaltrials.gov will be posted with Zenodo or by other means. The intent to release de-identified data was disclosed to each volunteer during the informed consent process.
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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.
Marcus W Migura principal investigator
Unafiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic Tourniquet, One Windlass Tourniquet and Two Windlass Tourniquets in people with Hemorrhage and Vascular Injury, run by Marcus Migura 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 13 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 24 Aug 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 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 24 Aug 2017). 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?
Radiologist Limb Occlusion Assessment (time frame: For 1 sustained minute after application of each tourniquet intervention.). 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?
On the ClinicalTrials.gov record for NCT02592655, which also lists 10 linked publications.
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 24 Aug 2017.