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

Primary Purpose

Acute Coagulopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood product transfusion based on conventional coagulation tests.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coagulopathy focused on measuring trauma, hemorrhagic shock, thrombelastography, coagulopathy, transfusion, resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Denver Health Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control (INR, PTT, fibrinogen, D-dimer)

Test (r-TEG)

Arm Description

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.

Outcomes

Primary Outcome Measures

28 Day In-hospital Mortality

Secondary Outcome Measures

Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).
Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).
Time to Death From Injury in Hours.
Change in INR Test Results.
A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
Change in Fibrinogen Test Results.
Change in Platelet Count Test Results.
Change in D-dimer Test Results.
Change in r-TEG ACT (Activated Clotting Time) Test Results.
Change in r-TEG Angle Test Results.
Change in r-TEG Maximal Amplitude (MA) Test Results.
Change in r-TEG LY30 Test Results.
Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury
Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.
Length of Stay (Days) in the Surgical Intensive Care Unit (SICU) Reported as ICU-free Days and Number of Days on the Ventialator Reported as Ventilator Free Days.
Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.
Multiple Organ Failure (MOF) score (Denver method) was calculated for the participants. This score rates the dysfunction of four organ systems (pulmonary, renal, hepatic, and cardiac), which are evaluated daily throughout the patient's intensive care unit stay and graded on a scale from 0 to 3, with the total score ranging from 0-12. Higher values on the score represent worse outcome. Participants with score above 3 were considered to have MOF.

Full Information

First Posted
July 19, 2011
Last Updated
December 15, 2018
Sponsor
Denver Health and Hospital Authority
Collaborators
Haemonetics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01536496
Brief Title
Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
Haemonetics Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: 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), r-TEG can be used to guide resuscitation strategy by permitting transfusion based upon individual patient deficits, r-TEG will result in appropriate transfusion of plasma, cryoprecipitate, and platelets in the individual trauma patient, r-TEG will result in reduced transfusion requirements in patients with post-injury coagulopathy. Our specific study aims are: 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. 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. 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. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coagulopathy
Keywords
trauma, hemorrhagic shock, thrombelastography, coagulopathy, transfusion, resuscitation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (INR, PTT, fibrinogen, D-dimer)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Test (r-TEG)
Arm Type
Active Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
Blood product transfusion based on conventional coagulation tests.
Intervention Description
Transfusion of blood products.
Intervention Type
Biological
Intervention Name(s)
Blood product transfusion based on rapid thrombelastography (r-TEG) results.
Intervention Description
Transfusion of blood products.
Primary Outcome Measure Information:
Title
28 Day In-hospital Mortality
Time Frame
28 days in hospital
Secondary Outcome Measure Information:
Title
Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).
Time Frame
Within 24 hours post-injury.
Title
Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).
Time Frame
Up to 28 days post-injury.
Title
Time to Death From Injury in Hours.
Time Frame
From time of injury to 28th day of hospitalization.
Title
Change in INR Test Results.
Description
A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
Time Frame
Within first 6 hours post-injury, 12 and 24 hours post-injury.
Title
Change in Fibrinogen Test Results.
Time Frame
Within first 6 hours post-injury, 12 and 24 hours post-injury.
Title
Change in Platelet Count Test Results.
Time Frame
Within first 6 hours post-injury, 12 and 24 hours post-injury.
Title
Change in D-dimer Test Results.
Time Frame
Within first 6 hours post-injury, 12 and 24 hours post-injury.
Title
Change in r-TEG ACT (Activated Clotting Time) Test Results.
Time Frame
Within first 6 hours post-injury, 12 and 24 hours post-injury.
Title
Change in r-TEG Angle Test Results.
Time Frame
Within first 6 hours post-injury, 12 and 24 hours post-injury.
Title
Change in r-TEG Maximal Amplitude (MA) Test Results.
Time Frame
Within first 6 hours post-injury, 12 and 24 hours post-injury.
Title
Change in r-TEG LY30 Test Results.
Time Frame
Within first 6 hours post-injury, 12 and 24 hours post-injury.
Title
Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury
Description
Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.
Time Frame
24 hours post-injury
Title
Length of Stay (Days) in the Surgical Intensive Care Unit (SICU) Reported as ICU-free Days and Number of Days on the Ventialator Reported as Ventilator Free Days.
Time Frame
28 days.
Title
Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.
Description
Multiple Organ Failure (MOF) score (Denver method) was calculated for the participants. This score rates the dysfunction of four organ systems (pulmonary, renal, hepatic, and cardiac), which are evaluated daily throughout the patient's intensive care unit stay and graded on a scale from 0 to 3, with the total score ranging from 0-12. Higher values on the score represent worse outcome. Participants with score above 3 were considered to have MOF.
Time Frame
Up to 30 days post-injury.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest E. Moore, M.D.
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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