ClinicalTrials.gov
ClinicalTrials.gov Menu

Survey of Tourniquet Use in a Combat Support Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00517166
Recruitment Status : Completed
First Posted : August 16, 2007
Last Update Posted : December 20, 2011
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research

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.

Condition or disease Intervention/treatment
Vascular Injury Device: CAT (Combat Arms Tourniquet)

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 Type : Observational
Actual Enrollment : 584 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Survey of Tourniquet Use in a Combat Support Hospital
Study Start Date : August 2006
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A
Individuals on whom tourniquet was used.
Device: CAT (Combat Arms Tourniquet)
device




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Combat soldiers on whom tourniquet was applied.
Criteria

Inclusion Criteria:

  • penetrating extremity injury with tourniquet use

Exclusion Criteria:

  • non penetrating extremity injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517166


Locations
Iraq
Combat Support Hospital
Baghdad, Iraq
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: John F Kragh, MD US Army Institute of Surgical Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00517166     History of Changes
Other Study ID Numbers: IRAQ 06-010
I.2006.175dt
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by United States Army Institute of Surgical Research:
tourniquet
extremity injury
hemostatic device

Additional relevant MeSH terms:
Vascular System Injuries
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries