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

Brief Summary:
To investigate the efficacy and safety of once daily enoxaparin as a "bridge" to warfarin for the outpatient treatment of acute deep venous thrombosis or pulmonary embolism.

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Enoxaparin Drug: Enoxaparin
Patient takes 1.5 mg per kilogram, once daily, subcutaneous injections until INR is therapeutic, then medication is stopped.
Other Name: Lovenox

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Death [ Time Frame: 30 Days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Symptomatic acute deep venous thrombosis and/or pulmonary embolism confirmed by venous ultrasound and/or CT scan.
  2. Pulmonary embolism patients with normal right ventricular size on chest CT scan.
  3. Age greater than 18 years
  4. Anticipated discharge within 72 hours of admission
  5. Written informed consent

Exclusion Criteria:

  1. Pregnancy or intend to become pregnant
  2. Patients requiring ongoing hospitalization > 72 hours
  3. Hypersensitivity to heparin, pork products or enoxaparin
  4. Creatinine > 2.0 mg/dl
  5. Recurrent DVT and/or PE with oral anticoagulation
  6. Surgery or medical procedure planned during the study that may pose a significant bleeding risk
  7. Prior history of heparin-induced thrombocytopenia
  8. Inability to participate for follow up appointments and study visits
  9. Life expectancy < 30 days
  10. High risk of bleeding:

    1. Active major bleeding within 30 days by GUSTO criteria
    2. History of intracranial bleeding
    3. Major surgery or trauma within 10 days
    4. Head injury requiring hospitalization within 1 year
    5. Intracranial tumor
    6. Neurosurgery or non-cataract ophthalmologic surgery within 1 month
    7. Thrombocytopenia

Information from the National Library of Medicine

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 identifier (NCT number): NCT00413374

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Samuel Z. Goldhaber, MD Brigham and Women's Hospital

Additional Information:
Responsible Party: Samuel Z.Goldhaber, MD, Director, VTE Research Group, Brigham and Women's Hospital Identifier: NCT00413374     History of Changes
Other Study ID Numbers: 2006-P-000082
First Posted: December 19, 2006    Key Record Dates
Results First Posted: April 30, 2012
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by Samuel Z.Goldhaber, MD, Brigham and Women's Hospital:
Pulmonary Embolism
Acute Deep Vein Thrombosis
Venous Thrombosis

Additional relevant MeSH terms:
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action