An interventional study of Pneumatic Tourniquet and One Windlass Tourniquet in Hemorrhage and Vascular Injury, sponsored by Marcus Migura. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-24.
Sponsored by Marcus Migura · Not applicable, Interventional, and Treatment
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.
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.
36 studies on the registry are indexed under Vascular System Injuries; 10 are open to participants now.
This study's enrollment of 19 is below the median of 70 across 22 interventional studies indexed under Vascular System Injuries.
Browse Vascular System Injuries studies →This is the only study on the registry with Marcus Migura as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Pneumatic Tourniquet
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.
Device: One Windlass Tourniquet · Device: Two Windlass Tourniquets
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.
Device: Tourniquet Tape 5 cm
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.
Device: Tourniquet Tape 10 cm
Automated pneumatic tourniquet, applied to middle upper thigh.
Also known as: Zimmer Automatic Tourniquet System (ATS) 1500
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.
Also known as: Special Operations Forces Tactical Tourniquet Wide (SOFTT-W)
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 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 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.
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.
Time frame: 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.
Time frame: For 1 sustained minute after application of each tourniquet intervention.
Healthy volunteers with a minimum upper thigh circumference of 61 cm were recruited from the general population during the first two weeks of December 2015.
| Milestone | All Participants |
|---|---|
| Started | 19 |
| Ats (pneumatic) | 5 |
| Windlass tourniquet | 7 |
| Tourniquet tape 10 cm width | 5 |
| Tourniquet tape 5 cm width | 2 |
| Completed | 19 |
| Not completed | 0 |
| Milestone | All Participants |
|---|---|
| Started | 19 |
| Ats (pneumatic) | 5 |
| Windlass tourniquet | 8 |
| Tourniquet tape 10 cm width | 5 |
| Tourniquet tape 5 cm width | 1 |
| Completed | 19 |
| Not completed | 0 |
| Milestone | All Participants |
|---|---|
| Started | 19 |
| Ats (pneumatic) | 8 |
| Windlass tourniquet | 4 |
| Tourniquet tape 10 cm width | 6 |
| Tourniquet tape 5 cm width | 1 |
| Completed | 19 |
| Not completed | 0 |
| Milestone | All Participants |
|---|---|
| Started | 4 |
| Ats (pneumatic) | 1 |
| Windlass tourniquet | 0 |
| Tourniquet tape 10 cm width | 3 |
| Tourniquet tape 5 cm width | 0 |
| Completed | 4 |
| Not completed | 0 |
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.
| Participants | Tourniquet Tape 10 cm | Pneumatic Tourniquet | One Windlass Tourniquet | Two Windlass Tourniquets |
|---|---|---|---|---|
| Success: Absent flow verified by radiologist. | 19 | 18 | 8 | 8 |
| Failure: Flow verified by radiologist. | 0 | 0 | 10 | 2 |
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.
| Participants | Tourniquet Tape 10 cm | Pneumatic Tourniquet | One Windlass Tourniquet | Two Windlass Tourniquets | Tourniquet Tape 5 cm |
|---|---|---|---|---|---|
| Success: Absent flow observed by investigator. | 19 | 19 | 8 | 9 | 3 |
| Failure: Flow observed by investigator. | 0 | 0 | 11 | 2 | 1 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pneumatic Tourniquet | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Windlass Tourniquet | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Tourniquet Tape 5 cm | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Tourniquet Tape 10 cm | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
"One Windlass" indicates the participants received only one windlass tourniquet because it appeared to be effective. "Two Windlass" describes the participants that received two windlass tourniquets because one did not appear to be effective. The total describes all participants. All participants received both the pneumatic and tape tourniquet.
| Age, Continuous(years) | One Windlass Tourniquet | Two Windlass Tourniquets | Total |
|---|---|---|---|
| Mean | 30.5 ± 9.5 | 36.1 ± 8.8 | 33.7 ± 9.25 |
| Sex: Female, Male(Participants) | One Windlass Tourniquet | Two Windlass Tourniquets | Total |
|---|---|---|---|
| Female | 0 | 4 | 4 |
| Male | 8 | 7 | 15 |
| Body Mass Index (BMI)(Kg/m^2) | One Windlass Tourniquet | Two Windlass Tourniquets | Total |
|---|---|---|---|
| Mean | 27.4 ± 1.7 | 36.1 ± 4.3 | 32.4 ± 5.6 |
| BMI Weight Status Category (CDC)(Participants) | One Windlass Tourniquet | Two Windlass Tourniquets | Total |
|---|---|---|---|
| BMI 18.5 - 24.9 Normal | 1 | 0 | 1 |
| BMI 25.0 - 29.9 Overweight | 7 | 1 | 8 |
| BMI 30.0 and Above Obese | 0 | 10 | 10 |
| Weight(kg) | One Windlass Tourniquet | Two Windlass Tourniquets | Total |
|---|---|---|---|
| Mean | 87.5 ± 11.0 | 111.3 ± 21.5 | 101.25 ± 21.22 |
| Height(cm) | One Windlass Tourniquet | Two Windlass Tourniquets | Total |
|---|---|---|---|
| Mean | 178.6 ± 9.7 | 175.0 ± 10.1 | 176.5 ± 9.8 |
| Thigh Circumference(cm) | One Windlass Tourniquet | Two Windlass Tourniquets | Total |
|---|---|---|---|
| Upper Thigh | 63.5 ± 3.7 | 71.2 ± 5.9 | 68.0 ± 6.3 |
| 10 cm above Mid Thigh | 61.0 ± 4.0 | 68.7 ± 5.7 | 65.4 ± 6.3 |
| Middle Thigh | 55 ± 4.2 | 60.3 ± 5.3 | 58.1 ± 5.5 |
| Lower Thigh | 42.3 ± 4.4 | 45.8 ± 3.1 | 44.3 ± 4.0 |
| Percentile of Mean Thigh Circumference(Percentile) | One Windlass Tourniquet | Two Windlass Tourniquets | Total |
|---|---|---|---|
| Upper thigh circumference percentile | 65 | 95 | 90 |
| Lower thigh circumference percentile | 75 | 95 | 90 |
3 further baseline measures are reported on the registry.
Plan to share: 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.
Supporting information: Icf, Csr
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