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

This study has been completed.
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: January 20, 2016
Last verified: January 2016
Results First Received: June 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Acute Coagulopathy
Interventions: Biological: Blood product transfusion based on conventional coagulation tests.
Biological: Blood product transfusion based on rapid thrombelastography (r-TEG) results.

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first patient was enrolled on 09/25/2010 and the last one was enrolled on 03/21/2014. The patients were enrolled when they met the inclusion criteria for the study, which were the criteria that activate the massive transfusion protocol. Enrollment occured upon arrival either in Emergency Room or in Operating Room.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

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.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:


Participant Flow:   Overall Study
    Control (INR, PTT, Fibrinogen, D-dimer)     Test (r-TEG)  
STARTED     57     57  
COMPLETED     55     56  
NOT COMPLETED     2     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control (INR, PTT, Fibrinogen, D-dimer) No text entered.
Test (r-TEG) No text entered.
Total Total of all reporting groups

Baseline Measures
    Control (INR, PTT, Fibrinogen, D-dimer)     Test (r-TEG)     Total  
Number of Participants  
[units: participants]
  55     56     111  
Age  
[units: years]
Median (Inter-Quartile Range)
  38  
  (25 to 55)  
  41  
  (28 to 54)  
  39  
  (28 to 55)  
Gender  
[units: participants]
     
Female     14     19     33  
Male     41     37     78  
Injury Severity Score (ISS) [1]
[units: Scores on a scale]
Median (Inter-Quartile Range)
  33  
  (25 to 43)  
  29.5  
  (23 to 41)  
  30  
  (24 to 43)  
Base Deficit (BD) [2]
[units: mEq/L]
Median (Inter-Quartile Range)
  13.7  
  (9 to 18)  
  11.0  
  (9 to 16)  
  12.0  
  (9 to 18)  
International Normalized Ratio (INR) [3]
[units: units on a scale]
Median (Inter-Quartile Range)
  1.46  
  (1.2 to 2.3)  
  1.45  
  (1.2 to 1.7)  
  1.45  
  (1.2 to 1.9)  
Platelet count [4]
[units: k/uL]
Median (Inter-Quartile Range)
  214  
  (165 to 279)  
  214  
  (145 to 318)  
  214  
  (150 to 291)  
Fibrinogen [5]
[units: mg/dL]
Median (Inter-Quartile Range)
  113  
  (68 to 139)  
  132  
  (94 to 240)  
  122  
  (75 to 201)  
D-dimer [6]
[units: ug/mL]
Median (Inter-Quartile Range)
  12.9  
  (6 to 20)  
  10.3  
  (2 to 20)  
  11.1  
  (4 to 20)  
TEG ACT (activated clotting time) [7]
[units: seconds]
Median (Inter-Quartile Range)
  128  
  (113 to 278)  
  128  
  (113 to 140)  
  128  
  (113 to 195)  
TEG Angle [8]
[units: degrees]
Median (Inter-Quartile Range)
  50.9  
  (28 to 69)  
  52.3  
  (30 to 70)  
  51.5  
  (29 to 69)  
TEG MA (maximal amplitude) [9]
[units: mm]
Median (Inter-Quartile Range)
  47.5  
  (34 to 53)  
  53.9  
  (28 to 63)  
  50.9  
  (31 to 60)  
TEG LY30 [10]
[units: percent of clot lysis at 30 minutes]
Median (Inter-Quartile Range)
  0.5  
  (0 to 4.4)  
  1.2  
  (0.1 to 4.2)  
  0.9  
  (0 to 4.3)  
[1] 0 to 75, higher score means worse outcome
[2] Base deficit refers to lack of bases in the blood. Bases are crucial in sustaining the acid-base homeostasis in the human body. Base deficit is an indicator of metabolic component of blood pH, as opposed to carbon dioxide, which is an indicator of respiratory component of blood pH. Base deficit outside of normal values (-2 to 2 mEq/L) usually means a shift in homeostasis towards acids or metabolic acidosis. More negative values are indicative of more profound disturbance in homeostasis.
[3] The reference range of the local clinical laboratory is 0.83-1.19. A high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
[4] The reference range of the local clinical laboratory is 150-400 k/uL.
[5] The reference range of the local clinical laboratory is 200.0-485.0 mg/dL.
[6] The reference range of the local clinical laboratory is <0.50 ug/mL.
[7] The reference range of the local clinical laboratory is 78.0-110.0.
[8] The reference range of the local clinical laboratory is 66.0-82.0 degrees.
[9] The reference range of the local clinical laboratory is 54.0-72.0 mm.
[10] The reference range of the local clinical laboratory is 0.0-7.4%. Percent of clot lysis 30 minutes after maximal amplitude (MA) was finalized.



  Outcome Measures
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1.  Primary:   28 Day In-hospital Mortality   [ Time Frame: 28 days in hospital ]

2.  Secondary:   Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).   [ Time Frame: Within 24 hours post-injury. ]

3.  Secondary:   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. ]

4.  Secondary:   Time to Death From Injury in Hours.   [ Time Frame: From time of injury to 28th day of hospitalization. ]

5.  Secondary:   Change in INR Test Results.   [ Time Frame: Within first 6 hours post-injury, 12 and 24 hours post-injury. ]

6.  Secondary:   Change in Fibrinogen Test Results.   [ Time Frame: Within first 6 hours post-injury, 12 and 24 hours post-injury. ]

7.  Secondary:   Change in Platelet Count Test Results.   [ Time Frame: Within first 6 hours post-injury, 12 and 24 hours post-injury. ]

8.  Secondary:   Change in D-dimer Test Results.   [ Time Frame: Within first 6 hours post-injury, 12 and 24 hours post-injury. ]

9.  Secondary:   Change in r-TEG ACT (Activated Clotting Time) Test Results.   [ Time Frame: Within first 6 hours post-injury, 12 and 24 hours post-injury. ]

10.  Secondary:   Change in r-TEG Angle Test Results.   [ Time Frame: Within first 6 hours post-injury, 12 and 24 hours post-injury. ]

11.  Secondary:   Change in r-TEG Maximal Amplitude (MA) Test Results.   [ Time Frame: Within first 6 hours post-injury, 12 and 24 hours post-injury. ]

12.  Secondary:   Change in r-TEG LY30 Test Results.   [ Time Frame: Within first 6 hours post-injury, 12 and 24 hours post-injury. ]

13.  Secondary:   Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury   [ Time Frame: 24 hours post-injury ]

14.  Secondary:   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. ]

15.  Secondary:   Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.   [ Time Frame: Up to 30 days post-injury. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ernest E. Moore
Organization: Denver Health Medical Center
phone: 303.602.1817
e-mail: Ernest.Moore@dhha.org



Responsible Party: Ernest Moore, 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
Results First Received: June 16, 2015
Last Updated: January 20, 2016
Health Authority: United States: Institutional Review Board