A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,450
- Locations
- 3
- Primary Endpoint
- To determine the prevalence and severity of immediate disturbances in coagulation by both RapidTEG and conventional coagulation parameters among major trauma activations.
Study Overview
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.
Detailed Description
This protocol is based on the fact that approximately 30% of severely injured military and civilian patients have disturbances of coagulation immediately upon arrival to the trauma center by traditional coagulation testing. It is hypothesized that:
- the coagulopathy of these patients may be detected more rapidly with RapidTEG than with traditional coagulation testing (prothrombin time, PT; international normalized ratio, INR; activated partial thromboplastin time, aPTT).
- the disturbances in the different RapidTEG parameters will correlate with early blood product utilization.
- the RapidTEG parameters will correlate closely with patient outcomes.
- the Rapid TEG will be able to describe the changes that occur with coagulation over time and do so for patients with different injury mechanisms and severities
This group has recently completed enrollment on the PRospective, Observational, Multi-center Massive Transfusion sTudy (PROMMTT) to evaluate the process, the decision-making, and outcomes associated with MT. This trial is supported by a ten million dollar grant from the U.S. Department of Defense for the Center for Translational Injury Research (CeTIR) and it investigators to conduct a multi-site observational study of severely injured trauma patients who require blood transfusions. Through our efforts, we hope to determine the best method of identifying patients who will benefit from receiving different ratios of red blood cells to plasma to platelets. This study was also designed to evaluate existing MT protocols at ten leading trauma centers and to identify which protocols are associated with better survival. Results of this study will be used to develop a future randomized clinical trial that will test these protocols.
Building on the authors proven experience with (1) predictive scoring methods to predict massive transfusion, (2) creation and maturation of a massive transfusion protocol, and (3) design of large, multi-institutional studies, the PROMMTT investigators will conduct a prospective cohort study of severely injured patients (major trauma activations) arriving to three ACS-verified academic Level 1 Trauma Centers, in which the following 3 aims will be addressed:
- To determine the prevalence and severity of immediate disturbances in coagulation by both RapidTEG and conventional coagulation parameters among major trauma activations.
- To determine if there are specific abnormalities of RapidTEG that correlate with specific early blood product utilization.
- To determine if RapidTEG abnormalities, when compared to kaolin-activated TEG, PT, INR and aPTT, correlate with patient outcomes in severely injured patients.
- To determine the temporal relationship between RapidTEG parameters and anatomic injury, mechanism of injury, and severity of injury.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Bryan Cotton
Visiting Associate Professor - Surgery
The University of Texas Health Science Center, Houston