Below Knee DVT Study

Oregon Health & Science University (OHSU)

Status and phase: Terminated; Phase 4

Conditions: Blood Clots; Deep Vein Thrombosis (DVT)

Treatments: Drug: Low Dose Enoxaparin; Drug: High Dose Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT03805672

9134

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Low Dose Enoxaparin

Active Comparator group

Description:

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

Treatment:

Drug: Low Dose Enoxaparin

High Dose Enoxaparin

Active Comparator group

Description:

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

Treatment:

Drug: High Dose Enoxaparin