Below Knee DVT Study

Deep Vein Thrombosis (DVT) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03805672
• Other study ID #: 9134
• Status: Terminated
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Clots
• Deep Vein Thrombosis (DVT)
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Low Dose Enoxaparin

• High Dose Enoxaparin

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deep Vein Thrombosis Resolution	Evaluation of DVT resolution	6 weeks