A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients (RapidTEG)
The purpose of this study is to evaluate the clinical utility of thrombelastography (TEG) to predict and identify trauma patients at increased risk of receiving blood transfusion, develop multiple organ failure and mortality.
TEG has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products and preclinical data suggest that TEG is both more sensitive and specific than PT or PTT for coagulation abnormalities. Based on the preclinical work led by Dr. Holcomb, our hypothesis is that the Rapid TEG will help to identify these coagulopathic patients earlier, allow for rapid MT protocol activation, and assist in developing data driven blood product transfusion guidelines.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients|
- 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 ] [ Designated as safety issue: No ]
- To determine if there are specific abnormalities of RapidTEG that correlate with specific early blood product utilization. [ Time Frame: First 5 days of hospitalization ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Adult trauma patients
Patients admitted to the emergency department (ED) as the highest level of acuity following a traumatic injury at three Level 1 trauma centers in the United States (UT Houston, UC San Francisco, Oregon Health Center).
Procedure: RapidTEG test
The RapidTEG test will be done at the study time points (3, 6, 12, 24 hours and 4 addiitonal days).
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228058
|United States, California|
|University of California - San Francisco|
|San Francisco, California, United States, 94110|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|Memorial Hermann Hospital - Texas Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bryan Cotton, MD||The University of Texas Health Science Center, Houston|