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

This study has been completed.
Sponsor:
Collaborator:
Haemonetics Corporation
Information provided by (Responsible Party):
Bryan Cotton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01228058
First received: October 20, 2010
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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 Intervention
Coagulopathy
Procedure: RapidTEG test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1450
Study Start Date: November 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228058

Locations
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
Investigators
Principal Investigator: Bryan Cotton, MD The University of Texas Health Science Center, Houston
  More Information

Publications:
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
Study First Received: October 20, 2010
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 01, 2014