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

This study is currently recruiting participants.
Verified March 2014 by Denver Health and Hospital Authority
Sponsor:
Collaborator:
Haemonetics Corporation
Information provided by (Responsible Party):
Ernest Moore, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01536496
First received: July 19, 2011
Last updated: March 10, 2014
Last verified: March 2014

July 19, 2011
March 10, 2014
September 2010
May 2014   (final data collection date for primary outcome measure)
  • Change in r-TEG parameters [TEG-ACT, alpha angle, K value, MA (maximum amplitude), G value (clot strength), and fibrinolysis (EPL=estimated percent lysis)]. [ Time Frame: On hospital admission (usually within an hour), twice within first 6 hours post-injury, 12 and 24 hours post-injury. ] [ Designated as safety issue: No ]
  • Change in conventional coagulation test results [aPTT, INR, platelet count, fibrinogen level, D-dimer]. [ Time Frame: On hospital admission (usually within an hour), twice within first 6 hours post-injury, 12 and 24 hours post-injury. ] [ Designated as safety issue: No ]
  • Quality and quantity of blood products transfused. [ Time Frame: Within 24 hours post-injury. ] [ Designated as safety issue: No ]

    Quantities of blood products transfused [packed red blood cells (RBCs), fresh frozen plasma (FFP), cryoprecipitate (cryoppt) and apheresis platelets (plts)] in the first 24 hours post-injury.

    Patterns of transfusion ratios of RBC: FFP: platelets in the first 24 hours post-injury.

  • Hemorrhage-related deaths specified as very early mortality (<2 hours post-injury), early mortality (2<6 hours post-injury) and delayed mortality (6-24 hours post-injury): incidence, cause and hours since injury. [ Time Frame: Within 24 hours post-injury. ] [ Designated as safety issue: No ]
  • Late mortality (>24 hours post-injury through day 30): incidence, cause and days since injury. [ Time Frame: Up to 30 days post-injury. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01536496 on ClinicalTrials.gov Archive Site
  • Cessation of coagulopathic bleeding based upon clinical impressions of the treating surgeons and review of operative records and outcome (hours since injury). [ Time Frame: Up to 24 hours post-injury. ] [ Designated as safety issue: No ]
  • Timeframe of all transfusions during the first 24 hours post-injury (stratified by: 0<2 hours, 2<4 hours, 4<6 hours, 6<12 hours, and 12-24 hours post-injury). [ Time Frame: Up to 24 hours post-injury. ] [ Designated as safety issue: No ]
  • Number of participants with Multiple Organ Failure (MOF) during this hospitalization. [ Time Frame: Up to 30 days post-injury. ] [ Designated as safety issue: No ]
    MOF score (Denver method) will be calculated.
  • Length of stay (days) in the surgical intensive care unit (SICU) and number of ventilator free days in the SICU. [ Time Frame: 28 days. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma
A Prospective, Randomized Comparison Of Rapid Thrombelastography (r-TEG) And Conventional Coagulation Testing For Guiding The Diagnosis And Haemostatic Resuscitation Of Trauma Patients At Risk For Post-Injury Coagulopathy

The purpose of this study is to compare rapid thrombelastography (r-TEG) with conventional coagulation testing for diagnosing and treating coagulation abnormalities in severely injured patients who are likely to require transfusion therapy.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Acute Coagulopathy
  • Biological: Blood product transfusion based on conventional coagulation tests.
    Transfusion of blood products.
  • Biological: Blood product transfusion based on rapid thrombelastography (r-TEG) results.
    Transfusion of blood products.
  • Active Comparator: Control (INR, PTT, fibrinogen, D-dimer)
    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.
    Intervention: Biological: Blood product transfusion based on conventional coagulation tests.
  • Active Comparator: Test (r-TEG)
    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.
    Intervention: Biological: Blood product transfusion based on rapid thrombelastography (r-TEG) results.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
August 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Arsen Ghasabyan, M.P.H. 303.602.3795 arsen.ghasabyan@dhha.org
Contact: Max Wohlauer, M.D. max.wohlauer@ucdenver.edu
United States
 
NCT01536496
COMIRB # 10-0477
Yes
Ernest Moore, Denver Health and Hospital Authority
Denver Health and Hospital Authority
Haemonetics Corporation
Principal Investigator: Ernest E. Moore, M.D. Denver Health
Denver Health and Hospital Authority
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP