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Terminated due to low enrollment because of decrease in DVT rates.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Enoxaparin | Active Comparator | Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution. |
|
| High Dose Enoxaparin | Active Comparator | Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Enoxaparin | Drug |
|
| |
| High Dose Enoxaparin |
| Measure | Description | Time Frame |
|---|---|---|
| Deep Vein Thrombosis Resolution | Evaluation of DVT resolution | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schreiber, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97206 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | High Dose Enoxaparin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Deep Vein Thrombosis Resolution | Evaluation of DVT resolution | Posted | Count of Participants | Participants | 6 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding at incision site | Injury, poisoning and procedural complications | Systematic Assessment | Subject experienced some increased bleeding at the incision site on lower extremity. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samantha Underwood | Oregon Health & Science University | 503-494-8481 | underwos@ohsu.edu |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Drug |
|
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | 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 | 0 | 2 | 0 | 2 | 1 | 2 |
|
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| D002241 |
| Carbohydrates |