Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism - Full Text View

Sponsors and Collaborators:	Brigham and Women's Hospital Sanofi-Aventis
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00413374

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

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Once Daily Enoxaparin for Outpatient Treatment of Acute Deep Venous Thrombosis and/or Pulmonary Embolism

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

Primary Outcome Measures:

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. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Major clotting complication as defined as recurrent acute pulmonary embolism confirmed on chest CT or deep vein thrombosis in the contralateral extremity confirmed with venous ultrasound or CT scan while on once daily enoxaparin therapy. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Death [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Patient takes 1.5 mg per kilogram, once daily, subcutaneous injections until INR is therapeutic, then medication is stopped.

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Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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-Aventis

Investigators

Principal Investigator:

Samuel Z. Goldhaber, MD

Brigham and Women's Hospital

More Information

North American Thrombosis Forum This link exits the ClinicalTrials.gov site

Publications:

Merli G, Spiro TE, Olsson CG, Abildgaard U, Davidson BL, Eldor A, Elias D, Grigg A, Musset D, Rodgers GM, Trowbridge AA, Yusen RD, Zawilska K; Enoxaparin Clinical Trial Group. Subcutaneous enoxaparin once or twice daily compared with intravenous unfractionated heparin for treatment of venous thromboembolic disease. Ann Intern Med. 2001 Feb 6;134(3):191-202.

Beckman JA, Dunn K, Sasahara AA, Goldhaber SZ. Enoxaparin monotherapy without oral anticoagulation to treat acute symptomatic pulmonary embolism. Thromb Haemost. 2003 Jun;89(6):953-8.

Kucher N, Quiroz R, McKean S, Sasahara AA, Goldhaber SZ. Extended enoxaparin monotherapy for acute symptomatic pulmonary embolism. Vasc Med. 2005 Nov;10(4):251-6.

Kucher N, Rossi E, De Rosa M, Goldhaber SZ. Prognostic role of echocardiography among patients with acute pulmonary embolism and a systolic arterial pressure of 90 mm Hg or higher. Arch Intern Med. 2005 Aug 8-22;165(15):1777-81.

Schoepf UJ, Kucher N, Kipfmueller F, Quiroz R, Costello P, Goldhaber SZ. Right ventricular enlargement on chest computed tomography: a predictor of early death in acute pulmonary embolism. Circulation. 2004 Nov 16;110(20):3276-80. Epub 2004 Nov 8.

Responsible Party:	Brigham and Women's Hospital ( Samuel Z. Goldhaber, MD )
Study ID Numbers:	2006-P-000082
Study First Received:	December 15, 2006
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00413374
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

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases

Vascular Diseases
Venous Thrombosis
Thrombosis
Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009