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| ID | Type | Description | Link |
|---|---|---|---|
| GSK576428 |
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The investigators hypothesize that Arixtra patients will be less likely to experience wound infection than patients who have received low-molecular weight heparin, coumadin or aspirin with mechanical compression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arixtra | Experimental | Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fondaparinux Sodium (Arixtra) | Drug | 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Until a Dry Wound | Days from day of surgery to stoppage of leakage from the wound | Up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days in Hospital. | Days after surgery to dischage | Up to 10 days |
| Incidence of Wound Infection | Incidence of Cellulitis in patients undergoing Arixtra treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul E. DiCesare, MD | University of California, Davis Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U C Davis | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arixtra | Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arixtra | Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Days Until a Dry Wound | Days from day of surgery to stoppage of leakage from the wound | Posted | Mean | Standard Deviation | days | Up to 10 days |
|
|
Length of hospital stay up to 10 days
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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 | Arixtra | Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gavin Pereira | UC Davis | 916-534-0919 | gcpereira@ucdavis.edu |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Up to 10 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Number of Days in Hospital. | Days after surgery to dischage | Posted | Mean | Standard Deviation | days | Up to 10 days |
|
|
|
| Secondary | Incidence of Wound Infection | Incidence of Cellulitis in patients undergoing Arixtra treatment | Posted | Count of Participants | Participants | Up to 10 days |
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| 0 |
| 114 |
| 0 |
| 114 |
| 2 |
| 114 |
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