Below Knee DVT Study

February 20, 2019 updated by: Martin A Schreiber, MD, Oregon Health and Science University

Is Therapeutic Anticoagulation Necessary for the Treatment of Distal Deep Venous Thrombosis of the Lower Extremity? A Randomized, Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97206
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Lovenox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep Vein Thrombosis Resolution
Time Frame: 6 weeks
Evaluation of DVT resolution
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 11, 2019

First Posted (ACTUAL)

January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deep Vein Thrombosis (DVT)

Clinical Trials on Low Dose Enoxaparin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe