Survey of Tourniquet Use in a Combat Support Hospital
| Tracking Information | |||||
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| First Received Date ICMJE | August 14, 2007 | ||||
| Last Updated Date | December 19, 2011 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00517166 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Survey of Tourniquet Use in a Combat Support Hospital | ||||
| Official Title ICMJE | Survey of Tourniquet Use in a Combat Support Hospital | ||||
| Brief 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. |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Combat soldiers on whom tourniquet was applied. |
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| Condition ICMJE | Vascular Injury | ||||
| Intervention ICMJE | Device: CAT (Combat Arms Tourniquet)
device |
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| Study Group/Cohort (s) | A
Individuals on whom tourniquet was used.
Intervention: Device: CAT (Combat Arms Tourniquet) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 584 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iraq | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00517166 | ||||
| Other Study ID Numbers ICMJE | IRAQ 06-010, I.2006.175dt | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | United States Army Institute of Surgical Research | ||||
| Study Sponsor ICMJE | United States Army Institute of Surgical Research | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | United States Army Institute of Surgical Research | ||||
| Verification Date | December 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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