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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT01228058 |
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Date of registration:
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20/10/2010 |
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Primary sponsor: |
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Public title:
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A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients
RapidTEG |
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Scientific title:
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A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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1450 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01228058 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Bryan Cotton, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Texas Health Science Center, Houston |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Major trauma patients who require the highest level of trauma team activation at each
site.
- Estimated age of 18 or higher
- Transfers less than 6 hours post-injury Exclusion Criteria: -Children less than 18
years of age.
- Burns > 20% of body surface area
- CPR pre-hospital
- Prisoners - defined as anyone directly admitted from a correctional facility
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coagulopathy
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Intervention(s)
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Procedure: RapidTEG test
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Primary Outcome(s)
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To determine the prevalence and severity of immediate disturbances in coagulation by both RapidTEG and conventional coagulation parameters among major trauma activations.
[Time Frame: First 5 days of hospitalization]
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Secondary Outcome(s)
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To determine if RapidTEG abnormalities, when compared to kaolin-activated TEG, PT, INR and aPTT, correlate with patient outcomes in severely injured patients.
[Time Frame: First 5 days of hospitalization]
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To determine if there are specific abnormalities of RapidTEG that correlate with specific early blood product utilization.
[Time Frame: First 5 days of hospitalization]
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To determine the temporal relationship between rapid TEG parameters and anatomic injury, mechanism of injury, and severity of injury.
[Time Frame: First 5 days of hospitalization]
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Secondary ID(s)
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HSC-MS-10-0160
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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