Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles (MicroTEC)
|ClinicalTrials.gov Identifier: NCT00908960|
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : December 12, 2013
Last Update Posted : December 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer||Drug: Enoxaparin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||October 2012|
Experimental: 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.
Other Name: Lovenox
No Intervention: High TFMP: Observation
Patients undergo observation until evaluation with a lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
No Intervention: Low TFMP: Observation
Patients undergo observation until evaluation with a lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
- 2-Month Cumulative Incidence of VTE [ Time Frame: Assessment with lower extremity ultrasound occured at day 60/ month 2 ]2-month cumulative incidence of venous thromboembolism (VTE) is the probability of experiencing within 2 months of study entry the following events: any symptomatic proximal or distal lower extremity deep vein thrombosis, symptomatic pulmonary embolism or fatal pulmonary embolism diagnosed by autopsy, or asymptomatic proximal deep vein thrombosis diagnosed by screening compression ultrasound.
- Incidence of Major Hemorrhage Events [ Time Frame: Assessed during the 60 day therapy ]Incidence is the number of patients experiencing at least one major hemorrhage events as defined according to International Society on Thrombosis and Haemostasis (ISTH) guidelines. (Schulman and Kearon 2005)
- Overall Survival [ Time Frame: Assessed up to approximately 30 months ]Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908960
|United States, California|
|University of Southern California-Keck School of Medicine|
|Los Angeles, California, United States, 90033|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|VA Boston Healthcare System|
|Boston, Massachusetts, United States, 02130|
|Mass General/North Shore Cancer Center|
|Danvers, Massachusetts, United States, 01923|
|Principal Investigator:||Jeffrey Zwicker, MD||Beth Israel Deaconess Medical Center|