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
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Study Type | Interventional |
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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 | |
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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. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 25 | 25 | 50 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | 25 participants | 50 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
25 100.0%
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25 100.0%
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50 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 25 participants | 25 participants | 50 participants | |
Female |
6 24.0%
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8 32.0%
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14 28.0%
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Male |
19 76.0%
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17 68.0%
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36 72.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 25 participants | 25 participants | 50 participants |
25 | 25 | 50 |
- 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
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 |
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 |