Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma
Acute Coagulopathy
About this trial
This is an interventional diagnostic trial for Acute Coagulopathy focused on measuring trauma, hemorrhagic shock, thrombelastography, coagulopathy, transfusion, resuscitation
Eligibility Criteria
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.
Sites / Locations
- Denver Health Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Control (INR, PTT, fibrinogen, D-dimer)
Test (r-TEG)
Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.