Blood Clots, Deep Vein Thrombosis (DVT)
Conditions
Keywords
Lovenox, enoxaparin, DVT
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.
Interventions
DRUGHigh Dose Enoxaparin
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deep Vein Thrombosis Resolution | 6 weeks | Evaluation of DVT resolution |
Countries
United States
Participant flow
Recruitment details
Patients 18 years or older who were admitted to the trauma or other surgical service and diagnosed during their hospital admission with an isolated distal DVT were invited to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Low Dose Enoxaparin Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.
Low Dose Enoxaparin | 2 |
| 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.
High Dose Enoxaparin | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | High Dose Enoxaparin | Total | Low Dose Enoxaparin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Continuous | 59.5 years STANDARD_DEVIATION 37.5 | 52.3 years STANDARD_DEVIATION 32 | 45.0 years STANDARD_DEVIATION 38.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Deep Vein Thrombosis Resolution
Evaluation of DVT resolution
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Enoxaparin | Deep Vein Thrombosis Resolution | 2 Participants |
| High Dose Enoxaparin | Deep Vein Thrombosis Resolution | 2 Participants |