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

NCT01228058 | Completed

• 1 other identifier: HSC-MS-10-0160
• Study Type: observational
• Target: 1,450
• Locations: 1 country
• Sites: 3

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.

Conditions

Coagulopathy

Keywords

Trauma; Coagulopathy; Coagulopathy in adult trauma patients

Outcome Measures

Primary Outcomes (1)

• To determine the prevalence and severity of immediate disturbances in coagulation by both RapidTEG and conventional coagulation parameters among major trauma activations.

  First 5 days of hospitalization

Secondary Outcomes (3)

• To determine if there are specific abnormalities of RapidTEG that correlate with specific early blood product utilization.

  First 5 days of hospitalization

• To determine if RapidTEG abnormalities, when compared to kaolin-activated TEG, PT, INR and aPTT, correlate with patient outcomes in severely injured patients.

  First 5 days of hospitalization

• To determine the temporal relationship between rapid TEG parameters and anatomic injury, mechanism of injury, and severity of injury.

  First 5 days of hospitalization

Study Arms (1)

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

Interventions

RapidTEG test PROCEDURE

The RapidTEG test will be done at the study time points (3, 6, 12, 24 hours and 4 addiitonal days).

Adult trauma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Major trauma patients who require the highest level of trauma team activation at each site.
• Estimated age of 18 or higher

You may not qualify if:

• Burns \> 20% of body surface area
• CPR pre-hospital
• Prisoners - defined as anyone directly admitted from a correctional facility

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Haemonetics Corporation: collaborator

Study Sites (3)

University of California - San Francisco

San Francisco, California, 94110, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (6)

• Acosta JA, Yang JC, Winchell RJ, Simons RK, Fortlage DA, Hollingsworth-Fridlund P, Hoyt DB. Lethal injuries and time to death in a level I trauma center. J Am Coll Surg. 1998 May;186(5):528-33. doi: 10.1016/s1072-7515(98)00082-9.

  PMID: 9583692 BACKGROUND

• Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma. 2003 Jun;54(6):1127-30. doi: 10.1097/01.TA.0000069184.82147.06.

  PMID: 12813333 BACKGROUND

• Cotton BA, Gunter OL, Isbell J, Au BK, Robertson AM, Morris JA Jr, St Jacques P, Young PP. Damage control hematology: the impact of a trauma exsanguination protocol on survival and blood product utilization. J Trauma. 2008 May;64(5):1177-82; discussion 1182-3. doi: 10.1097/TA.0b013e31816c5c80.

  PMID: 18469638 BACKGROUND

• Niles SE, McLaughlin DF, Perkins JG, Wade CE, Li Y, Spinella PC, Holcomb JB. Increased mortality associated with the early coagulopathy of trauma in combat casualties. J Trauma. 2008 Jun;64(6):1459-63; discussion 1463-5. doi: 10.1097/TA.0b013e318174e8bc.

  PMID: 18545109 BACKGROUND

• MacLeod JB, Lynn M, McKenney MG, Cohn SM, Murtha M. Early coagulopathy predicts mortality in trauma. J Trauma. 2003 Jul;55(1):39-44. doi: 10.1097/01.TA.0000075338.21177.EF.

  PMID: 12855879 BACKGROUND

• Cotton BA, Au BK, Nunez TC, Gunter OL, Robertson AM, Young PP. Predefined massive transfusion protocols are associated with a reduction in organ failure and postinjury complications. J Trauma. 2009 Jan;66(1):41-8; discussion 48-9. doi: 10.1097/TA.0b013e31819313bb.

  PMID: 19131804 BACKGROUND

MeSH Terms

Conditions

Hemostatic Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bryan Cotton, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Associate Professor - Surgery

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 25, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

US (3)