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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00517166
Other study ID # IRAQ 06-010
Secondary ID I.2006.175dt
Status Completed
Phase N/A
First received August 14, 2007
Last updated December 19, 2011
Start date August 2006
Est. completion date March 2008

Study information

Verified date December 2011
Source United States Army Institute of Surgical Research
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 584
Est. completion date March 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- penetrating extremity injury with tourniquet use

Exclusion Criteria:

- non penetrating extremity injury

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Device:
CAT (Combat Arms Tourniquet)
device

Locations

Country Name City State
Iraq Combat Support Hospital Baghdad

Sponsors (1)

Lead Sponsor Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

Iraq, 

See also
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Completed NCT02592655 - A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet N/A
Completed NCT02975518 - Tracking Endothelial Cells in Arterial Injury N/A
Completed NCT05538858 - Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study