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:

1. 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),

2. r-TEG can be used to guide resuscitation strategy by permitting transfusion based upon
individual patient deficits,

3. r-TEG will result in appropriate transfusion of plasma, cryoprecipitate, and platelets
in the individual trauma patient,

4. r-TEG will result in reduced transfusion requirements in patients with post-injury
coagulopathy.

Our specific study aims are:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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:

1. Male or female, age >18 years admitted to Denver Health Medical Center.

2. 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:

1. Age < 18 years.

2. 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).

3. Known inherited defects of coagulation function (e.g. hemophilia, Von Willebrand's
disease).

4. Prisoner.

5. Pregnancy.