NCT01536496.

Trial name or title	Comparison of rapid thromboelastography and conventional coagulation testing for haemostatic resuscitation in trauma
Methods	Randomized parallel assignment open‐label Estimated enrolment: 114
Participants	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. haemophilia, Von Willebrand's disease) 4. prisoner 5. pregnancy
Interventions	Intervention group: blood product transfusion based on rapid thromboelastography (r‐TEG) results 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 postinjury 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, anaesthesiologist) and then two further r‐TEG analyses at 12 hours and at 24 hours postinjury, 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 Control group: blood product transfusion based on conventional coagulation tests 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 postinjury 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 postinjury. 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
Outcomes	Primary outcome measures: 1. change in r‐TEG parameters (TEG‐ACT, alpha angle, K value, maximum amplitude, G value (clot strength), and fibrinolysis (EPL = estimated percent lysis)). (On hospital admission (usually within an hour), twice within first 6 hours postinjury, 12, and 24 hours postinjury) 2. change in conventional coagulation test results (aPTT, INR, platelet count, fibrinogen level, D‐dimer). (On hospital admission (usually within an hour), twice within first 6 hours postinjury, 12, and 24 hours postinjury) 3. Quality and quantity of blood products transfused (within 24 hours postinjury). Quantities of blood products transfused (PRBCs, FFP, cryoprecipitate, and apheresis platelets) in the first 24 hours postinjury) 4. patterns of transfusion ratios of RBC: FFP: platelets in the first 24 hours postinjury 5. haemorrhage‐related deaths specified as very early mortality (< 2 hours postinjury), early mortality (2 < 6 hours postinjury) 6. delayed mortality (6‐24 hours postinjury) ‐ incidence, cause and hours since injury (within 24 hours postinjury) 7. late mortality (> 24 hours postinjury through day 30) ‐ incidence, cause and days since injury (up to 30 days postinjury) Secondary outcome measures: 1. cessation of coagulopathic bleeding based upon clinical impressions of the treating surgeons and review of operative records and outcome (hours since injury ‐ up to 24 hours postinjury) 2. timeframe of all transfusions during the first 24 hours postinjury (stratified by: 0 < 2 hours, 2 < 4 hours, 4 < 6 hours, 6 < 12 hours, and 12‐24 hours postinjury) 3. number of participants with multiple organ failure during this hospitalizations (Up to 30 days postinjury) 4. multiple organ failure score (Denver method) will be calculated 5. length of stay (days) in the surgical ICU and number of ventilator‐free days in the surgical ICU (within 28 days)
Starting date	Start date September 2010; estimated completion date July 2014
Contact information	Ernest Moore, Director, Surgery/Trauma Service, Denver Health and Hospital Authority, Colorado, United States, ernest.moore@dhha.org
Notes	NCT01536496 Authors had been contacted on 5 May 2015, and September 2015, but with no response