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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
Sponsor:
Information provided by (Responsible Party):
Martin A Schreiber, MD, Oregon Health and Science University

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.


Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis (DVT) Blood Clots Drug: Low Dose Enoxaparin Drug: High Dose Enoxaparin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Deep Vein Thrombosis Resolution [ Time Frame: 6 weeks ]
    Evaluation of DVT resolution



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97206
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Martin Schreiber, MD Oregon Health and Science University

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Responsible Party: Martin A Schreiber, MD, Professor & Chief of Trauma, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03805672     History of Changes
Other Study ID Numbers: 9134
First Posted: January 16, 2019    Key Record Dates
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019
Last Verified: February 2019

Keywords provided by Martin A Schreiber, MD, Oregon Health and Science University:
Lovenox
enoxaparin
DVT

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action