Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00413374
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : April 30, 2012
Last Update Posted : April 30, 2012
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
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
Enoxaparin Recieved low molecular weight heparin (LMWH) as a "bridge" to warfarin

Participant Flow:   Overall Study
Ineligible due to screening criteria.                3 
Adverse Event                1 
Lost to Follow-up                1 
Surgery                1 

  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
Enoxaparin Recieved low molecular weight heparin (LMWH) as a "bridge" to warfarin

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   35 
>=65 years   5 
[Units: Years]
Mean (Standard Deviation)
 47.95  (16.2) 
[Units: Participants]
Female   21 
Male   19 
Region of Enrollment 
[Units: Participants]
United States   40 

  Outcome Measures

1.  Primary:   Major Bleeding Complication   [ Time Frame: 30 Days ]

2.  Primary:   Recurrent VTE   [ Time Frame: 30 Days ]

3.  Primary:   Death   [ Time Frame: 30 Days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  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
No text entered.

  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: Research Coordinator
Organization: Brigham and Women's Hospital
phone: 617-732-6984


Responsible Party: Samuel Z.Goldhaber, MD, Brigham and Women's Hospital Identifier: NCT00413374     History of Changes
Other Study ID Numbers: 2006-P-000082
First Submitted: December 15, 2006
First Posted: December 19, 2006
Results First Submitted: June 22, 2011
Results First Posted: April 30, 2012
Last Update Posted: April 30, 2012