Vascular InjuryNCT00517166
Survey of Tourniquet Use in a Combat Support Hospital
An observational study of Vascular Injury, run by United States Army Institute of Surgical Research at 1 site in Iraq.
Trial summary
Data will be collected on the type of tourniquet and circumstances of its use. Patients with penetrating extremity injury will have clinical and pre-clinical hospital data collected. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vascular Injury
- What is being tested?
- CAT (Combat Arms Tourniquet)
- Type of treatment
- Medical device
- How many people
- 584 participants
- Where
- 1 siteIraq
- Study dates
- Aug 2006to Mar 2008
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Combat soldiers on whom tourniquet was applied.
Who may be able to join
- penetrating extremity injury with tourniquet use
Who cannot join
- non penetrating extremity injury
Trial locations and contacts
1 site in 1 country.
About this study
Data will be collected on the type of tourniquet and circumstances of its use. Patients with penetrating extremity injury will have clinical and pre-clinical hospital data collected.
Read the detailed description
This is a performance improvement project that is a prospective observational cohort design with subgroup analyses. This project meets the criteria of research with its intent to publish. No data is generated and only existing data are used. No interventions are made and the comparisons will be with within subgroups in the cohort.
Aim 1. Describe the number of tourniquets which were appropriately used (wound required a tourniquet and tourniquet was placed properly) as assessed by treating physician
Aim 2 \&3. Describe if limbs wounds with tourniquets were bleeding upon admission, resuscitation, and following tourniquet removal
Aim 4. Describe if mortality for the cohort of patients with tourniquets is different than the mortality predicted by various injury scoring systems
Aim 5. Compare patient outcomes between those in which a tourniquet was indicated but not used and those for whom a tourniquet was indicated and used
Aim 6. Determine if patients that received tourniquets for an extended time period exhibit any known tourniquet complications
- Conditions
- Vascular Injury
- Being tested
- CAT (Combat Arms Tourniquet)
- Keywords
- tourniquet, extremity injury, hemostatic device
- Medical subject headings
- Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT (Combat Arms Tourniquet)Device
device
| Study group | Role | What they receive |
|---|---|---|
| A | Individuals on whom tourniquet was used. Receives: Device: CAT (Combat Arms Tourniquet) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startAug 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vascular InjuryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John F Kragh, MD, Principal investigator, US Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517166
- Sponsor's protocol ID
- IRAQ 06-010
- Other IDs
- I.2006.175dt
- Status last verified
- Dec 2011
- First submitted
- 14 Aug 2007
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kragh JF Jr, O'Neill ML, Walters TJ, Jones JA, Baer DG, Gershman LK, Wade CE, Holcomb JB. Minor morbidity with emergency tourniquet use to stop bleeding in severe limb trauma: research, history, and reconciling advocates and abolitionists. Mil Med. 2011 Jul;176(7):817-23. doi: 10.7205/milmed-d-10-00417.
PubMed 22128725Kragh JF Jr, O'Neill ML, Beebe DF, Fox CJ, Beekley AC, Cain JS, Parsons DL, Mabry RL, Blackbourne LH. Survey of the indications for use of emergency tourniquets. J Spec Oper Med. 2011 Winter;11(1):30-34. doi: 10.55460/36SQ-1UQU.
PubMed 21455908Kragh JF Jr, Littrel ML, Jones JA, Walters TJ, Baer DG, Wade CE, Holcomb JB. Battle casualty survival with emergency tourniquet use to stop limb bleeding. J Emerg Med. 2011 Dec;41(6):590-7. doi: 10.1016/j.jemermed.2009.07.022. Epub 2009 Aug 31.
PubMed 19717268Kragh JF Jr, Walters TJ, Baer DG, Fox CJ, Wade CE, Salinas J, Holcomb JB. Survival with emergency tourniquet use to stop bleeding in major limb trauma. Ann Surg. 2009 Jan;249(1):1-7. doi: 10.1097/SLA.0b013e31818842ba.
PubMed 19106667
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Tourniquet Use in a Combat Support Hospital
- ClinicalTrials.gov ID
- NCT00517166
- Acronym / sponsor ID
- IRAQ 06-010
- Conditions
- Vascular Injury
- Keywords
- tourniquet, extremity injury, hemostatic device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Aug 2006
- Study completion
- Mar 2008 (actual)
- First posted
- 16 Aug 2007 (estimated)
- 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.
Data will be collected on the type of tourniquet and circumstances of its use. Patients with penetrating extremity injury will have clinical and pre-clinical hospital data collected.
Detailed description
This is a performance improvement project that is a prospective observational cohort design with subgroup analyses. This project meets the criteria of research with its intent to publish. No data is generated and only existing data are used. No interventions are made and the comparisons will be with within subgroups in the cohort.
Aim 1. Describe the number of tourniquets which were appropriately used (wound required a tourniquet and tourniquet was placed properly) as assessed by treating physician
Aim 2 \&3. Describe if limbs wounds with tourniquets were bleeding upon admission, resuscitation, and following tourniquet removal
Aim 4. Describe if mortality for the cohort of patients with tourniquets is different than the mortality predicted by various injury scoring systems
Aim 5. Compare patient outcomes between those in which a tourniquet was indicated but not used and those for whom a tourniquet was indicated and used
Aim 6. Determine if patients that received tourniquets for an extended time period exhibit any known tourniquet complications
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: CAT (Combat Arms Tourniquet)Individuals on whom tourniquet was used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Combat soldiers on whom tourniquet was applied.
Key inclusion criteria (1 listed)
- penetrating extremity injury with tourniquet use
Key exclusion criteria (1 listed)
- non penetrating extremity injury
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 |
|---|---|---|
| CAT (Combat Arms Tourniquet)device | Device | A |
Primary outcome
Not reported in the source record.
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 20 Dec 2011.
- Derived from this study: PubMed 22128725Kragh JF Jr, O'Neill ML, Walters TJ, Jones JA, Baer DG, Gershman LK, Wade CE, Holcomb JB. Minor morbidity with emergency tourniquet use to stop bleeding in severe limb trauma: research, history, and reconciling advocates and abolitionists. Mil Med. 2011 Jul;176(7):817-23. doi: 10.7205/milmed-d-10-00417.
- Derived from this study: PubMed 21455908Kragh JF Jr, O'Neill ML, Beebe DF, Fox CJ, Beekley AC, Cain JS, Parsons DL, Mabry RL, Blackbourne LH. Survey of the indications for use of emergency tourniquets. J Spec Oper Med. 2011 Winter;11(1):30-34. doi: 10.55460/36SQ-1UQU.
- Derived from this study: PubMed 19717268Kragh JF Jr, Littrel ML, Jones JA, Walters TJ, Baer DG, Wade CE, Holcomb JB. Battle casualty survival with emergency tourniquet use to stop limb bleeding. J Emerg Med. 2011 Dec;41(6):590-7. doi: 10.1016/j.jemermed.2009.07.022. Epub 2009 Aug 31.
- Derived from this study: PubMed 19106667Kragh JF Jr, Walters TJ, Baer DG, Fox CJ, Wade CE, Salinas J, Holcomb JB. Survival with emergency tourniquet use to stop bleeding in major limb trauma. Ann Surg. 2009 Jan;249(1):1-7. doi: 10.1097/SLA.0b013e31818842ba.
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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.
John F Kragh, MD principal investigator
US Army Institute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Injury, run by United States Army Institute of Surgical Research at 1 site in Iraq.
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 1 inclusion and 1 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 20 Dec 2011. 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 Iraq. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00517166, which also lists 4 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 20 Dec 2011.