Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism
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|ClinicalTrials.gov Identifier: NCT00413374|
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : April 30, 2012
Last Update Posted : April 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis Pulmonary Embolism||Drug: Enoxaparin||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Once Daily Enoxaparin for Outpatient Treatment of Acute Deep Venous Thrombosis and/or Pulmonary Embolism|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||December 2008|
Patient takes 1.5 mg per kilogram, once daily, subcutaneous injections until INR is therapeutic, then medication is stopped.
Other Name: Lovenox
- Major Bleeding Complication [ Time Frame: 30 Days ]Major bleeding complication as defined as spinal, retroperitoneal, or intracranial bleeding; drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding.
- Recurrent VTE [ Time Frame: 30 Days ]Major clotting complication (recurrent VTE) as defined as recurrent acute pulmonary embolism confirmed on chest CT or recurrent deep vein thrombosis in the contralateral extremity confirmed with venous ultrasound or CT scan while on once daily enoxaparin therapy.
- Death [ Time Frame: 30 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413374
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Samuel Z. Goldhaber, MD||Brigham and Women's Hospital|