Below Knee DVT Study

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Deep Vein Thrombosis (DVT) Blood Clots

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Dose Enoxaparin

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

Group Type ACTIVE_COMPARATOR

Low Dose Enoxaparin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

High Dose Enoxaparin

Intervention Type DRUG

Interventions

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Low Dose Enoxaparin

Intervention Type DRUG

High Dose Enoxaparin

Intervention Type DRUG

Other Intervention Names

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Lovenox Lovenox

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No