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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Acute Coagulopathy
Biological: Blood product transfusion based on conventional coagulation tests.
Biological: Blood product transfusion based on rapid thrombelastography (r-TEG) results.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Blood product transfusion based on conventional coagulation tests.
Transfusion of blood products.
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.
Biological: Blood product transfusion based on rapid thrombelastography (r-TEG) results.
Transfusion of blood products.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536496

Contacts
Contact: Arsen Ghasabyan, M.P.H. 303.602.3795 arsen.ghasabyan@dhha.org
Contact: Max Wohlauer, M.D. max.wohlauer@ucdenver.edu

Locations
United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Principal Investigator: Ernest E. Moore, M.D.         
Sponsors and Collaborators
Denver Health and Hospital Authority
Haemonetics Corporation
Investigators
Principal Investigator: Ernest E. Moore, M.D. Denver Health
  More Information

No publications provided

Responsible Party: Ernest Moore, Director, Surgery/Trauma Service, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01536496     History of Changes
Other Study ID Numbers: COMIRB # 10-0477
Study First Received: July 19, 2011
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:
trauma
hemorrhagic shock
thrombelastography
coagulopathy
transfusion
resuscitation

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014