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

NCT00413374 | Completed Results DMC

• 1 other identifier: 2006-P-000082
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Vein Thrombosis; Pulmonary Embolism

Keywords

Lovenox; Enoxaparin; Prophylaxis; Pulmonary Embolism; Acute Deep Vein Thrombosis; Venous Thrombosis; Thrombosis; Anticoagulation

Outcome Measures

Primary Outcomes (3)

• Major Bleeding Complication

  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.

  30 Days

• Recurrent VTE

  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.

  30 Days

• Death

  All-cause mortality

  30 Days

Study Arms (1)

Enoxaparin

OTHER

Drug: Enoxaparin

Interventions

Enoxaparin DRUG

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

Also known as: Lovenox

Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Active major bleeding within 30 days by GUSTO criteria
• History of intracranial bleeding
• Major surgery or trauma within 10 days
• Head injury requiring hospitalization within 1 year
• Intracranial tumor

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Sanofi: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• 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. doi: 10.7326/0003-4819-134-3-200102060-00009.

  PMID: 11177331 BACKGROUND

• 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.

  PMID: 12783106 BACKGROUND

• 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. doi: 10.1191/1358863x05vm634oa.

  PMID: 16444853 BACKGROUND

• 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. doi: 10.1001/archinte.165.15.1777.

  PMID: 16087827 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000147612.59751.4C. Epub 2004 Nov 8.

  PMID: 15533868 BACKGROUND

Related Links

• North American Thrombosis Forum

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Research Coordinator
• Organization: Brigham and Women's Hospital

arao2@partners.org

617-732-6984

Study Officials

• Samuel Z. Goldhaber, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, VTE Research Group

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 19, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 28, 2018
• Results First Posted: April 30, 2012

Record last verified: 2018-05

Locations

US (1)