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

• Sponsor: Denver Health and Hospital Authority (Other)
• Overall Status: Completed
• CT.gov ID: NCT01050153
• Collaborator: Eisai Inc. (Industry)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

This study plans to learn more about how to prevent blood clots in the veins of your extremities. You are at risk of forming these clots after a major injury and when you have had surgery and are hospitalized on bed rest.

Usually, patients in the SICU at Denver Health who are at risk for blood clots receive preventative treatment with a FDA-approved medicine called Fragmin. Fragmin is intended to prevent blood clots from forming but, with the way it is generally used, some patients may still develop blood clots. All patients treated with Fragmin to prevent blood clots at Denver Health, currently receive the same Fragmin dose. This treatment is called the "standard of care".

So far, in the US, there has not been a commonly available test that can tell us:

• if the standard dose of Fragmin is enough to prevent blood clots for everyone, or

• if different patients need different doses, or

• if other blood clot preventing medicines, that work in a different way, should be used in addition to Fragmin.

The ability of your blood to clot and the strength of the clot formed can be described by a FDA-approved blood test called thrombelastography, referred to as TEG. TEG may provide us with answers to each of the questions above. Our preliminary data indicate that it is helpful in assessing both clotting and bleeding tendencies and may prove useful in guiding treatment for the prevention of blood clots.

The aim of this study is to determine if a treatment plan using Fragmin, and, if indicated, one or two additional FDA-approved medicines called anti-platelet drugs, guided by the results of TEG testing, may be better at preventing blood clots than our current standard of care.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism	Drug: Dalteparin sodium; Drug: Dalteparin sodium/aspirin	N/A

Detailed Description

This preliminary/pilot study involves a prospective, randomized, open-label, parallel group comparison of Denver Health's current standard of care for prevention of venous thromboembolism (VTE), commonly known as blood clots, using LMWH (Fragmin) 5000IU subcutaneously daily, with a thrombelastography (TEG)-guided, algorithm-based, individualized regimen of LMWH (Fragmin) plus/minus anti-platelet therapy (aspirin) guided by platelet mapping, in patients admitted to the SICU following trauma.

Approximately 50 trauma patients for whom prevention of VTE with LMWH is indicated, will be enrolled over a six month period.

The specific aims of this study are as follows:

1. To determine the incidence of, and to characterize, hypercoagulability using TEG and conventional clinical coagulation testing (APTT, INR), Antithrombin III levels and Protein C activity.

2. In the group of patients receiving LMWH (Fragmin) therapy alone for prevention of VTE:

3. to assess the anticoagulant effect of standard LMWH (Fragmin) dosing (5000IU subcutaneously once daily) using TEG and Anti-Factor Xa level measurement, and

4. to determine the extent of correlation of relevant TEG parameters with measured Anti-Factor Xa levels (U/ml).

5. To assess whether TEG is a useful clinical tool for monitoring and optimizing prophylactic LMWH (Fragmin) therapy and for identifying the need for anti-platelet therapy to minimize the risk of VTE in these patients.

6. To evaluate the clinical utility of platelet mapping for guiding anti-platelet therapy in those patients for whom it is indicated by TEG results.

7. To determine the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in each randomized group and in the subgroup receiving anti-platelet therapy in addition to LMWH (Fragmin) for prevention of VTE.

The overall aim is to utilize the above data to evaluate a) the adequacy of our standard Fragmin dosing regimen (5000IU subcutaneously once daily) alone for prevention of VTE in our trauma/SICU patients, b) the need for anti-platelet agents in addition to LMWH (Fragmin) for prevention of VTE in our population, and c) to validate/further develop the TEG-guided algorithm for optimal prophylaxis of VTE using LMWH (Fragmin) plus/minus anti-platelet therapy guided by platelet mapping.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: An Evaluation of the Clinical Utility of Thrombelastography (TEG) in Guiding Low Molecular Weight Heparin (LMWH) and Antiplatelet Prophylaxis of Venous Thromboembolism (VTE) Following Trauma
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control (standard of care) Dalteparin sodium 5000IU subcutaneously daily	Drug: Dalteparin sodium; Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory; Other Names: Dalteparin sodium (Fragmin)
Experimental: TEG-guided thromboprophylaxis Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm	Drug: Dalteparin sodium/aspirin; Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily) po.; Other Names: dalteparin sodium (Fragmin)

Outcome Measures

Primary Outcome Measures

1. Hypercoagulability [Study day five.]

   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.

2. Incidence of VTE [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)

Secondary Outcome Measures

1. TEG Parameters [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.

2. International Normalized Ratio (INR) [Study day five.]

   Plasma based conventional coagulation testing parameters

3. Platelet Count [Study day five.]

   Platelet count measured by CBC test

4. TEG Parameters [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.

5. Conventional Coagulation Testing Parameters [Study day five.]

   Plasma based conventional coagulation testing parameters - Anti Xa

6. Conventional Coagulation Testing Parameters [Study day five.]

   Plasma based conventional coagulation testing parameters - Fibrinogen

7. Conventional Coagulation Testing Parameters [Study day five.]

   Plasma based conventional coagulation testing parameters - Anti-thrombin III

8. Conventional Coagulation Testing Parameters [Study day five.]

   Plasma based conventional coagulation testing parameters - Protein C

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age at least 18 years,

• blunt or penetrating trauma requiring admission to the SICU

• requirement for LMWH (Fragmin) therapy for prophylaxis of VTE as standard of care, and

• informed consent by patient, legally authorized representative or proxy decision maker (if patient incompetent to provide) obtained and documented.

Exclusion Criteria:

Presence of any of the following absolute contraindications to LMWH (Fragmin) therapy:

• known hypersensitivity to dalteparin sodium,

• known hypersensitivity to heparin or pork products,

• thrombocytopenia associated with positive tests for antiplatelet antibody in the presence of Fragmin,

• history of heparin-induced thrombocytopenia (HIT),

• chronic liver disease (bilirubin >2 mg/dl) or kidney insufficiency (CrCl <30mL/min),

• intravascular thrombolytic therapy within 24 hours,

• resuscitation that required massive transfusion (>10 units RBC within 6 hours),

• ongoing resuscitation for hemorrhagic shock,

• known bleeding disorder or coagulopathy (INR >2 not on warfarin),

• thrombocytopenia (platelets <20K/uL),

• subdural or epidural hematoma.

Or

Presence of any of the following relative contraindications to LMWH (Fragmin) therapy:

• new intracranial lesions, neoplasms or monitoring devices,

• extravascular thrombolytic therapy,

• severe uncontrolled hypertension,

• arterial dissection

• recent (within 12 hours) intraocular surgery (prior or planned),

• recent (within 72 hours) intracranial or spine surgery (prior or planned),

• conditions associated with increased risk of hemorrhage, e.g. active gastrointestinal ulceration, angiodysplastic disease, gastrointestinal bleeding within the past six months, bacterial endocarditis, history of hemorrhagic stroke, diabetic retinopathy.

Or

Presence, or removal within the last 12 hours, of an indwelling epidural or spinal catheter, OR recent (within the last 12 hours) or planned neuraxial (spinal/epidural) anesthesia or spinal puncture.

Or

Per history taken from patient or family, concomitant or known use within one week prior to hospitalization, of drugs affecting hemostasis such as NSAIDS, platelet inhibitors or other anticoagulants, except as specified in this protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Denver Health Medical Center	Denver	Colorado	United States	80203

Sponsors and Collaborators

• Denver Health and Hospital Authority
• Eisai Inc.

Investigators

• Principal Investigator: Ernest E. Moore Jr, M.D., Chief, Department of Surgery and Trauma Services , Denver Health Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Ernest E. Moore, MD, Chief, Department of Surgery and Trauma Services Rocky Mountain Regional Trauma Center, Denver Health and Hospital Authority
• ClinicalTrials.gov Identifier: NCT01050153
• Other Study ID Numbers: COMIRB # 09-0753
• First Posted: Jan 15, 2010
• Last Update Posted: Jan 8, 2019
• Last Verified: Dec 1, 2018

• Keywords provided by Ernest E. Moore, MD, Chief, Department of Surgery and Trauma Services Rocky Mountain Regional Trauma Center, Denver Health and Hospital Authority: Prevention of venous thromboembolism
• Additional relevant MeSH terms: Thromboembolism; Venous Thromboembolism; Aspirin; Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight

Study Results

Participant Flow

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.

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

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 Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	25 100%	50 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.04 (12.18)	38.44 (14.34)	39.24 (13.19)
Sex: Female, Male (Count of Participants)
Female	6 24%	8 32%	14 28%
Male	19 76%	17 68%	36 72%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	50 100%

Outcome Measures

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.
Measure Participants	21	18
Number [participants]	16 64%	18 72%

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.
Measure Participants	25	25
Number [participants]	0 0%	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.
Measure Participants	21	18
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.
Measure Participants	20	19
Mean (Standard Error) [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.
Measure Participants	22	21
Mean (Standard Deviation) [* 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.
Measure Participants	21	18
Mean (Standard Error) [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.
Measure Participants	20	19
Mean (Standard Error) [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.
Measure Participants	20	19
Mean (Standard Error) [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.
Measure Participants	20	19
Mean (Standard Error) [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.
Measure Participants	20	19
Mean (Standard Error) [percentage of activity]	76.65 (6.17)	79.83 (7.6)

Adverse Events

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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control (Standard of Care)		TEG-guided Thromboprophylaxis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Control (Standard of Care)		TEG-guided Thromboprophylaxis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		1/25 (4%)
Blood and lymphatic system disorders
Decrease in Hemoglobin level more than 2g/dL in 24 hour period.	0/25 (0%)	0	1/25 (4%)	1

Limitations/Caveats

lower than expected incidence of VTE events Control group patients were followed for 5 days, while TEG-guided group was followed as long as in SICU adherence to VTE prophylaxis with Daltaparin was significantly low in the TEG-guided group

More Information

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.