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

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

Participant Flow

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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
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.
Period Title: Overall Study
Started	25	25
Completed	25	25
Not Completed	0	0

Baseline Characteristics

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Arm/Group Title		Control (Standard of Care)	TEG-guided Thromboprophylaxis	Total
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
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

Outcome Measures

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1. Primary Outcome

Title	Hypercoagulability
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard of Care)	TEG-guided Thromboprophylaxis
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
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard of Care)	TEG-guided Thromboprophylaxis
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)
Description	Plasma based conventional coagulation testing parameters
Time Frame	Study day five.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard of Care)	TEG-guided Thromboprophylaxis
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
Description	Platelet count measured by CBC test
Time Frame	Study day five.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard of Care)	TEG-guided Thromboprophylaxis
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
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard of Care)	TEG-guided Thromboprophylaxis
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
Description	Plasma based conventional coagulation testing parameters - Anti Xa
Time Frame	Study day five.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard of Care)	TEG-guided Thromboprophylaxis
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
Description	Plasma based conventional coagulation testing parameters - Fibrinogen
Time Frame	Study day five.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard of Care)	TEG-guided Thromboprophylaxis
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
Description	Plasma based conventional coagulation testing parameters - Anti-thrombin III
Time Frame	Study day five.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard of Care)	TEG-guided Thromboprophylaxis
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
Description	Plasma based conventional coagulation testing parameters - Protein C
Time Frame	Study day five.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard of Care)	TEG-guided Thromboprophylaxis
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)

Adverse Events

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Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Control (Standard of Care)		TEG-guided Thromboprophylaxis
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	--/--		--/--
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%)
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

Limitations and Caveats

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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

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: 303.602.1820

EMail: Ernest.Moore@dhha.org

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