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A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients (RapidTEG)

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: NCT01228058
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : December 18, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Coagulopathy Procedure: RapidTEG test

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Study Design

Study Type : Observational
Actual Enrollment : 1450 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients
Study Start Date : November 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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).

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine if there are specific abnormalities of RapidTEG that correlate with specific early blood product utilization. [ Time Frame: First 5 days of hospitalization ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population for this study is all major-trauma patients admitted to one of the three participating ACS-verified academic Level 1 trauma centers.

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
Contacts and Locations

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): 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
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Haemonetics Corporation
Principal Investigator: Bryan Cotton, MD The University of Texas Health Science Center, Houston
More Information

Responsible Party: Bryan Cotton, Visiting Associate Professor - Surgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01228058     History of Changes
Other Study ID Numbers: HSC-MS-10-0160
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Bryan Cotton, The University of Texas Health Science Center, Houston:
Coagulopathy in adult trauma patients

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders