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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 : October 20, 2015
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Ernest Moore, 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Control (Standard of Care)   TEG-guided Thromboprophylaxis
STARTED   25   25 
COMPLETED   25   25 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Control (Standard of Care)   TEG-guided Thromboprophylaxis   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 25   25   50 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   25   25   50 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 40.04  (12.18)   38.44  (14.34)   39.24  (13.19) 
Gender 
[Units: Participants]
 		     
Female   6   8   14 
Male   19   17   36 
Region of Enrollment 
[Units: Participants]
 		     
United States   25   25   50 


  Outcome Measures

1.  Primary:   Hypercoagulability   [ Time Frame: Study day five. ]
  Show Outcome Measure 1

2.  Primary:   Incidence of VTE   [ Time Frame: Day 28 or discharge, whichever comes first. ]
  Show Outcome Measure 2

3.  Secondary:   TEG Parameters   [ Time Frame: Study day five. ]
  Show Outcome Measure 3

4.  Secondary:   International Normalized Ratio (INR)   [ Time Frame: Study day five. ]
  Show Outcome Measure 4

5.  Secondary:   Platelet Count   [ Time Frame: Study day five. ]
  Show Outcome Measure 5

6.  Secondary:   TEG Parameters   [ Time Frame: Study day five. ]
  Show Outcome Measure 6

7.  Secondary:   Conventional Coagulation Testing Parameters   [ Time Frame: Study day five. ]
  Show Outcome Measure 7

8.  Secondary:   Conventional Coagulation Testing Parameters   [ Time Frame: Study day five. ]
  Show Outcome Measure 8

9.  Secondary:   Conventional Coagulation Testing Parameters   [ Time Frame: Study day five. ]
  Show Outcome Measure 9

10.  Secondary:   Conventional Coagulation Testing Parameters   [ Time Frame: Study day five. ]
  Show Outcome Measure 10


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  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

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
e-mail: Ernest.Moore@dhha.org



Responsible Party: Ernest Moore, 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: October 20, 2015