Is Therapeutic Anticoagulation Necessary for the Treatment of Distal Deep Venous Thrombosis of the Lower Extremity? A Randomized, Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Low Dose Enoxaparin
- Conditions
- Deep Vein Thrombosis (DVT)
- Sponsor
- Oregon Health and Science University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Deep Vein Thrombosis Resolution
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
Hospitalized patients are at risk of developing blood clots in the legs (Deep Vein Thrombosis or DVT), which can lead to death if those clots break off and migrate to the lungs. We know that if there is a blood clot in the large leg veins near the hips and in the thighs, treating these patients with high-doses of blood thinners reduces the risk of these deaths.
It is unclear if treating blood clots in the calf with high doses of blood thinners is better than using low doses. In this study, after being diagnosed with a blood clot in the calf, patients will be treated with either low dose or high dose enoxaparin (Lovenox), a blood thinner. We will then see if low dose blood thinner has similar results as high dose blood thinner.
Investigators
Martin A Schreiber, MD
Professor & Chief of Trauma
Oregon Health and Science University
Eligibility Criteria
Inclusion Criteria
- •Patients over the age of 18 admitted to a trauma or general surgery service will be eligible
- •Patients diagnosed with an isolated distal DVT
- •Able to obtain informed consent
Exclusion Criteria
- •Patients with a previous diagnosis of hypercoagulability
- •Patients on chronic anticoagulation
- •Patients with a history of heparin induced thrombocytopenia
- •Patients have preexisting contraindications to anticoagulation
- •Patients in renal failure requiring adjusted enoxaparin dosing
- •Pregnant patients
Arms & Interventions
Low Dose Enoxaparin
Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.
Intervention: Low Dose Enoxaparin
High Dose Enoxaparin
Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution.
Intervention: High Dose Enoxaparin
Outcomes
Primary Outcomes
Deep Vein Thrombosis Resolution
Time Frame: 6 weeks
Evaluation of DVT resolution