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Below Knee DVT Study

Primary Purpose

Deep Vein Thrombosis (DVT), Blood Clots

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Low Dose Enoxaparin
High Dose Enoxaparin
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis (DVT) focused on measuring Lovenox, enoxaparin, DVT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low Dose Enoxaparin

High Dose Enoxaparin

Arm Description

Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.

Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution.

Outcomes

Primary Outcome Measures

Deep Vein Thrombosis Resolution
Evaluation of DVT resolution

Secondary Outcome Measures

Full Information

First Posted
January 14, 2015
Last Updated
February 20, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03805672
Brief Title
Below Knee DVT Study
Official Title
Is Therapeutic Anticoagulation Necessary for the Treatment of Distal Deep Venous Thrombosis of the Lower Extremity? A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low enrollment because of decrease in DVT rates.
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis (DVT), Blood Clots
Keywords
Lovenox, enoxaparin, DVT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Enoxaparin
Arm Type
Active Comparator
Arm Description
Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.
Arm Title
High Dose Enoxaparin
Arm Type
Active Comparator
Arm Description
Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution.
Intervention Type
Drug
Intervention Name(s)
Low Dose Enoxaparin
Other Intervention Name(s)
Lovenox
Intervention Type
Drug
Intervention Name(s)
High Dose Enoxaparin
Other Intervention Name(s)
Lovenox
Primary Outcome Measure Information:
Title
Deep Vein Thrombosis Resolution
Description
Evaluation of DVT resolution
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schreiber, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97206
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Below Knee DVT Study

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