Below Knee DVT Study

Phase 4

Terminated

• Conditions: Deep Vein Thrombosis (DVT); Blood Clots
• Interventions: Drug: Low Dose Enoxaparin; Drug: High Dose Enoxaparin

• Registration Number: NCT03805672
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-01-14
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-16
• Status Verified: 2019-02
• Results First Submitted: 2019-02-20
• Results First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Results First Posted: 2019-03-13
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Enoxaparin	Low Dose Enoxaparin	Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.
High Dose Enoxaparin	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.

Primary Outcome Measures

Name	Time	Method
Deep Vein Thrombosis Resolution	6 weeks	Evaluation of DVT resolution

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States