Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma

This is a prospective, randomized study comparing rapid thrombelastography (r-TEG) with conventional coagulation testing for diagnosing post-injury coagulopathy and guiding haemostatic resuscitation strategy in severely injured patients arriving at the trauma center who are likely to require transfusion therapy.

Our global hypothesis is that:

• r-TEG is an effective tool for early identification of specific coagulation abnormalities via real time analysis, providing rapid results at the point of care (POC),
• r-TEG can be used to guide resuscitation strategy by permitting transfusion based upon individual patient deficits,
• r-TEG will result in appropriate transfusion of plasma, cryoprecipitate, and platelets in the individual trauma patient,
• r-TEG will result in reduced transfusion requirements in patients with post-injury coagulopathy.

Our specific study aims are:

• To compare r-TEG parameters [TEG-ACT, alpha angle, K value, MA (maximum amplitude), G value (clot strength), and fibrinolysis (EPL=estimated percent lysis)] with conventional coagulation testing [aPTT, INR, platelet count, fibrinogen level, D-dimer] in their ability to diagnose and monitor coagulation abnormalities in the trauma patient specifically.
• To compare blood product administration (packed red blood cells, fresh frozen plasma, cryoprecipitate and apheresis platelets) in the first 24 hours post-injury when transfusion is guided by r-TEG versus conventional coagulation tests.
• To determine whether normalization of r-TEG values predicts cessation of coagulopathic bleeding better than normalization of conventional clinical coagulation tests based upon clinical impressions of the treating surgeons and review of operative records and outcome.
• To determine and compare patterns of transfusion ratios of packed red blood cells: fresh frozen plasma: platelets for resuscitation of patients with post-injury coagulopathy in the r-TEG versus conventional coagulation test guided groups for the first 24 hours post-injury.
• To determine and compare the timeframes of blood product administration throughout the first 24 hours post-injury when transfusion is guided by r-TEG versus conventional coagulation testing.
• To compare the incidence of hemorrhage-related deaths as: very early mortality (<2 hours post-injury), early (2<6 hours post-injury) and delayed (6-24 post-injury) based upon review of death/autopsy records for date, time and cause of death in patients whose resuscitation is guided by r-TEG versus conventional coagulation testing.
• To compare a) the incidence of transfusion associated lung injury (TRALI), transfusion associated circulatory overload (TACO), acute respiratory distress syndrome (ARDS), and multiple organ failure (MOF); b) the length of stay in the surgical intensive care unit (SICU) and the number of ventilator free days in the SICU; and c) late mortality (>24 hour to Day 30), including day number and cause of death, in patients whose resuscitation is guided by r-TEG versus conventional coagulation testing.

Inclusion criteria

• Male or female, age >18 years admitted to Denver Health Medical Center.
• Blunt or penetrating trauma sustained < 6 hours before admission, with Injury Severity Score > 15 (ISS>15), likely to require transfusion of RBC within 6 hours from admission as indicated by clinical assessment.

Exclusion criteria

• Age < 18 years.
• Documented chronic liver disease (total bilirubin >2.0 mg/dL). Advanced cirrhosis discovered on laparotomy will be a criterion for study withdrawal and exclusion of conventional coagulation or r-TEG/TEG data from the analysis).
• Known inherited defects of coagulation function (e.g. hemophilia, Von Willebrand's disease).
• Prisoner.
• Pregnancy.