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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00413374
First received: December 15, 2006
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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 Intervention
Deep Vein Thrombosis
Pulmonary Embolism
Drug: Enoxaparin

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Once Daily Enoxaparin for Outpatient Treatment of Acute Deep Venous Thrombosis and/or Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Major Bleeding Complication [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413374

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

Additional Information:
Publications:
Responsible Party: Samuel Z.Goldhaber, MD, Director, VTE Research Group, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00413374     History of Changes
Other Study ID Numbers: 2006-P-000082
Study First Received: December 15, 2006
Results First Received: June 22, 2011
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Lovenox
Enoxaparin
Prophylaxis
Pulmonary Embolism
Acute Deep Vein Thrombosis
Venous Thrombosis
Thrombosis
Anticoagulation

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014