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The Clinical Utility of Thrombelastography in Guiding Prophylaxis of Venous Thromboembolism Following Trauma (VTEPX)

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ClinicalTrials.gov Identifier: NCT01050153
Recruitment Status : Completed
First Posted : January 15, 2010
Results First Posted : April 25, 2014
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Ernest E. Moore, MD, Denver Health and Hospital Authority

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Venous Thromboembolism
Interventions Drug: Dalteparin sodium
Drug: Dalteparin sodium/aspirin
Enrollment 50
Recruitment Details 50 consecutive eligible patients admitted to the Surgical Intensive Care Unit following trauma between March 2010 and December 2011 were enrolled in the study.
Pre-assignment Details  
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
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Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis Total
Hide Arm/Group Description

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
40.04  (12.18) 38.44  (14.34) 39.24  (13.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
6
  24.0%
8
  32.0%
14
  28.0%
Male
19
  76.0%
17
  68.0%
36
  72.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Hypercoagulability
Hide Description To determine the incidence of, and to characterize, hypercoagulability in a sample of trauma patients admitted to the SICU at DHMC using TEG and conventional clinical coagulation testing (APTT, INR), antithrombin III levels and protein C activity. Hypercoagulability is defined as TEG parameter G (clot strength) >10.9.
Time Frame Study day five.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The reason for having 21 participants in the Control group and 18 participants in the TEG-guided group is that 21 and 18 participants in the respective groups stayed five days or longer. Four participants (25-21) in the Control group and seven participants (25-18) in the TEG-guided group stayed less than five days.
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description:

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Overall Number of Participants Analyzed 21 18
Measure Type: Number
Unit of Measure: participants
16 18
2.Primary Outcome
Title Incidence of VTE
Hide Description The incidence and nature of hypercoagulability and the incidence of deep vein thrombosis and pulmonary embolism in each randomized group and in the subgroup receiving anti-platelet therapy in addition to Fragmin (descriptive analysis only)
Time Frame Day 28 or discharge, whichever comes first.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description:

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: participants
0 0
3.Secondary Outcome
Title TEG Parameters
Hide Description

R is a reaction time. The time from the start of a sample run until the first significant levels of detectable clot formation (amplitude = 2 mm in the TEG tracing).

Rf is a difference in reaction time between Fragmin-active and Fragmin-neutralized samples.

Achievement of a certain clot strength K is a measure of the time from R until a fixed level of clot strength is reached (amplitude = 20 mm).

Angle or α measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This most represents fibrinogen level. Angle relates to K, since both are a function of the rate of clot formation.

MA, or Maximum Amplitude, is a direct function of the maximum clot strength. In tests where platelets are part of the clot, this parameter most reflects platelet function/aggregation. Clot strength is the result of two components - the modest contribution of fibrin and the much more significant contribution of the platelets.

Time Frame Study day five.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description:

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Overall Number of Participants Analyzed 21 18
Mean (Standard Error)
Unit of Measure: Minutes
R value 5.89  (0.38) 5.83  (0.35)
Rf value -0.09  (0.09) -0.34  (0.16)
4.Secondary Outcome
Title International Normalized Ratio (INR)
Hide Description Plasma based conventional coagulation testing parameters
Time Frame Study day five.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description:

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: ratio
1.23  (0.19) 1.13  (0.09)
5.Secondary Outcome
Title Platelet Count
Hide Description Platelet count measured by CBC test
Time Frame Study day five.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description:

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: * 10^3 platelets/µL
261.64  (171.73) 267.76  (83.23)
6.Secondary Outcome
Title TEG Parameters
Hide Description

Shear elastic modulus strength (SEMS). The MA parameter can be transformed into the actual measure of clot strength (G) using the formula below, and is measured in dyn/cm2 divided by 1000 (displayed in the software as Kd/sc).

The absolute SEMS of the sample can be calculated from MA as follows:

G = (5000MA/(100-MA))/1000 An amplitude of 50 mm corresponds to a SEMS of 5000 dyn/cm2. An increase in MA from 50 mm to 67 mm is equivalent to a two-fold increase in the SEMS. The G parameter not only provides a measurement of clot firmness in force units, but also is more indicative of small changes in the clot strength or clot breakdown than is the amplitude in mm because it is an exponential reflection of MA.

Time Frame Study day five.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description:

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Overall Number of Participants Analyzed 21 18
Mean (Standard Error)
Unit of Measure: Kd/sc
14.97  (0.91) 15.46  (0.60)
7.Secondary Outcome
Title Conventional Coagulation Testing Parameters
Hide Description Plasma based conventional coagulation testing parameters - Anti Xa
Time Frame Study day five.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description:

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: IU/mL
0.14  (0.01) 0.18  (0.01)
8.Secondary Outcome
Title Conventional Coagulation Testing Parameters
Hide Description Plasma based conventional coagulation testing parameters - Fibrinogen
Time Frame Study day five.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description:

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: mg/dL
691.4  (146.69) 687.11  (157.75)
9.Secondary Outcome
Title Conventional Coagulation Testing Parameters
Hide Description Plasma based conventional coagulation testing parameters - Anti-thrombin III
Time Frame Study day five.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description:

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: percentage of activity
79.3  (4.31) 80  (4.31)
10.Secondary Outcome
Title Conventional Coagulation Testing Parameters
Hide Description Plasma based conventional coagulation testing parameters - Protein C
Time Frame Study day five.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description:

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: percentage of activity
76.65  (6.17) 79.83  (7.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control (Standard of Care) TEG-guided Thromboprophylaxis
Hide Arm/Group Description

Dalteparin sodium 5000IU subcutaneously daily

Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po.

All-Cause Mortality
Control (Standard of Care) TEG-guided Thromboprophylaxis
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control (Standard of Care) TEG-guided Thromboprophylaxis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Control (Standard of Care) TEG-guided Thromboprophylaxis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      1/25 (4.00%)    
Blood and lymphatic system disorders     
Decrease in Hemoglobin level more than 2g/dL in 24 hour period.   0/25 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
  1. lower than expected incidence of VTE events
  2. Control group patients were followed for 5 days, while TEG-guided group was followed as long as in SICU
  3. adherence to VTE prophylaxis with Daltaparin was significantly low in the TEG-guided group
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: 303.602.1820
Responsible Party: Ernest E. Moore, MD, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01050153     History of Changes
Other Study ID Numbers: COMIRB # 09-0753
First Submitted: January 13, 2010
First Posted: January 15, 2010
Results First Submitted: August 14, 2013
Results First Posted: April 25, 2014
Last Update Posted: January 8, 2019