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Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles (MicroTEC)

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ClinicalTrials.gov Identifier: NCT00908960
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : December 12, 2013
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer
Intervention: Drug: Enoxaparin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
High TFMP: Enoxaparin Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
High TFMP: Observation Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
Low TFMP: Observation Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.

Participant Flow:   Overall Study
    High TFMP: Enoxaparin   High TFMP: Observation   Low TFMP: Observation
STARTED   24   12   34 
Evaluable   23   11   32 
COMPLETED   23   11   32 
NOT COMPLETED   1   1   2 
Presence VTE dx or Absent VTE eval                1                1                2 



  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.
The analysis dataset is comprised of all evaluable patients.

Reporting Groups
  Description
High TFMP: Enoxaparin

Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).

Only patients with high TFMP status at baseline were randomized to treatment or observation.

High TFMP: Observation Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
Low TFMP: Observation Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
Total Total of all reporting groups

Baseline Measures
   High TFMP: Enoxaparin   High TFMP: Observation   Low TFMP: Observation   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   11   32   66 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10  43.5%      4  36.4%      19  59.4%      33  50.0% 
>=65 years      13  56.5%      7  63.6%      13  40.6%      33  50.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.3  (10.5)   63.4  (15.0)   63.3  (11.7)   64.0  (11.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      9  39.1%      6  54.5%      13  40.6%      28  42.4% 
Male      14  60.9%      5  45.5%      19  59.4%      38  57.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   23   11   32   66 


  Outcome Measures

1.  Primary:   2-Month Cumulative Incidence of VTE   [ Time Frame: Assessment with lower extremity ultrasound occured at day 60/ month 2 ]

2.  Secondary:   Incidence of Major Hemorrhage Events   [ Time Frame: Assessed during the 60 day therapy ]

3.  Secondary:   Overall Survival   [ Time Frame: Assessed up to approximately 30 months ]


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeffrey Zwicker, MD
Organization: Beth Israel Deaconess Medical Center
phone: 617-667-9299
e-mail: jzwicker@bidmc.harvard.edu


Publications of Results:

Responsible Party: Jeffrey Zwicker, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00908960     History of Changes
Other Study ID Numbers: 08-378
First Submitted: May 26, 2009
First Posted: May 27, 2009
Results First Submitted: July 22, 2013
Results First Posted: December 12, 2013
Last Update Posted: December 19, 2017