Below Knee DVT Study
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|ClinicalTrials.gov Identifier: NCT03805672|
Recruitment Status : Terminated (Terminated due to low enrollment because of decrease in DVT rates.)
First Posted : January 16, 2019
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis (DVT) Blood Clots||Drug: Low Dose Enoxaparin Drug: High Dose Enoxaparin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Is Therapeutic Anticoagulation Necessary for the Treatment of Distal Deep Venous Thrombosis of the Lower Extremity? A Randomized, Controlled Trial|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Active Comparator: Low Dose Enoxaparin
Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.
Drug: Low Dose Enoxaparin
Other Name: Lovenox
Active Comparator: 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.
Drug: High Dose Enoxaparin
Other Name: Lovenox
- Deep Vein Thrombosis Resolution [ Time Frame: 6 weeks ]Evaluation of DVT resolution
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 ClinicalTrials.gov identifier (NCT number): NCT03805672
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97206|
|Principal Investigator:||Martin Schreiber, MD||Oregon Health and Science University|