Trial Outcomes & Findings for The Clinical Utility of Thrombelastography in Guiding Prophylaxis of Venous Thromboembolism Following Trauma (NCT NCT01050153)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Study day five.

Results posted on

2019-01-08

Participant Flow

50 consecutive eligible patients admitted to the Surgical Intensive Care Unit following trauma between March 2010 and December 2011 were enrolled in the study.

Participant milestones

Participant milestones
Measure	Control (Standard of Care) Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory	TEG-guided Thromboprophylaxis 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 Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control (Standard of Care) n=25 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory	TEG-guided Thromboprophylaxis n=25 Participants 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 n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.04 years STANDARD_DEVIATION 12.18 • n=5 Participants	38.44 years STANDARD_DEVIATION 14.34 • n=7 Participants	39.24 years STANDARD_DEVIATION 13.19 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Study day five.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	TEG-guided Thromboprophylaxis n=18 Participants 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.	Control (Standard of Care) n=21 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
Hypercoagulability	18 participants	16 participants

PRIMARY outcome

Timeframe: Day 28 or discharge, whichever comes first.

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)

Outcome measures

Outcome measures
Measure	TEG-guided Thromboprophylaxis n=25 Participants 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.	Control (Standard of Care) n=25 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
Incidence of VTE	0 participants	0 participants

SECONDARY outcome

Timeframe: Study day five.

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.

Outcome measures

Outcome measures
Measure	TEG-guided Thromboprophylaxis n=18 Participants 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.	Control (Standard of Care) n=21 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
TEG Parameters R value	5.83 Minutes Standard Error 0.35	5.89 Minutes Standard Error 0.38
TEG Parameters Rf value	-0.34 Minutes Standard Error 0.16	-0.09 Minutes Standard Error 0.09

SECONDARY outcome

Timeframe: Study day five.

Plasma based conventional coagulation testing parameters

Outcome measures

Outcome measures
Measure	TEG-guided Thromboprophylaxis n=19 Participants 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.	Control (Standard of Care) n=20 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
International Normalized Ratio (INR)	1.13 ratio Standard Error 0.09	1.23 ratio Standard Error 0.19

SECONDARY outcome

Timeframe: Study day five.

Platelet count measured by CBC test

Outcome measures

Outcome measures
Measure	TEG-guided Thromboprophylaxis n=21 Participants 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.	Control (Standard of Care) n=22 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
Platelet Count	267.76 * 10^3 platelets/µL Standard Deviation 83.23	261.64 * 10^3 platelets/µL Standard Deviation 171.73

SECONDARY outcome

Timeframe: Study day five.

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.

Outcome measures

Outcome measures
Measure	TEG-guided Thromboprophylaxis n=18 Participants 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.	Control (Standard of Care) n=21 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
TEG Parameters	15.46 Kd/sc Standard Error 0.60	14.97 Kd/sc Standard Error 0.91

SECONDARY outcome

Timeframe: Study day five.

Plasma based conventional coagulation testing parameters - Anti Xa

Outcome measures

Outcome measures
Measure	TEG-guided Thromboprophylaxis n=19 Participants 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.	Control (Standard of Care) n=20 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
Conventional Coagulation Testing Parameters	0.18 IU/mL Standard Error 0.01	0.14 IU/mL Standard Error 0.01

SECONDARY outcome

Timeframe: Study day five.

Plasma based conventional coagulation testing parameters - Fibrinogen

Outcome measures

Outcome measures
Measure	TEG-guided Thromboprophylaxis n=19 Participants 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.	Control (Standard of Care) n=20 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
Conventional Coagulation Testing Parameters	687.11 mg/dL Standard Error 157.75	691.4 mg/dL Standard Error 146.69

SECONDARY outcome

Timeframe: Study day five.

Plasma based conventional coagulation testing parameters - Anti-thrombin III

Outcome measures

Outcome measures
Measure	TEG-guided Thromboprophylaxis n=19 Participants 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.	Control (Standard of Care) n=20 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
Conventional Coagulation Testing Parameters	80 percentage of activity Standard Error 4.31	79.3 percentage of activity Standard Error 4.31

SECONDARY outcome

Timeframe: Study day five.

Plasma based conventional coagulation testing parameters - Protein C

Outcome measures

Outcome measures
Measure	TEG-guided Thromboprophylaxis n=19 Participants 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.	Control (Standard of Care) n=20 Participants Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
Conventional Coagulation Testing Parameters	79.83 percentage of activity Standard Error 7.6	76.65 percentage of activity Standard Error 6.17

Adverse Events

Control (Standard of Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TEG-guided Thromboprophylaxis

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control (Standard of Care) n=25 participants at risk Dalteparin sodium 5000IU subcutaneously daily Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory	TEG-guided Thromboprophylaxis n=25 participants at risk 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.
Blood and lymphatic system disorders Decrease in Hemoglobin level more than 2g/dL in 24 hour period.	0.00% 0/25	4.0% 1/25 • Number of events 1

Additional Information

Ernest E. Moore

Denver Health Medical Center

Phone: 303.602.1820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place