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| Name | Class |
|---|---|
| Haemonetics Corporation | INDUSTRY |
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This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. Patients will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arixtra Arm | Active Comparator | Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks |
|
| Pneumatic compression stockings arm | Active Comparator | Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arixtra | Drug |
| ||
| Pneumatic compression stockings |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss | requiring transfusion | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Deep Vein Thrombosis | verified by ultrasound | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Arixtra Arm | Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks Arixtra Aspirin |
| FG001 | Pneumatic Compression Stockings Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) |
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| Aspirin | Drug |
|
| Sinai Center for Thrombosis Research |
| Baltimore |
| Maryland |
| 21215 |
| United States |
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arixtra Arm | Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks Arixtra Aspirin |
| BG001 | Pneumatic Compression Stockings Arm | Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks. Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) Aspirin |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Blood Loss | requiring transfusion | Posted | Number | participants | 6 weeks |
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| Secondary | Deep Vein Thrombosis | verified by ultrasound | Posted | Number | participants | 6 weeks |
|
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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 Arm | Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks Arixtra Aspirin | 0 | 0 | 0 | 0 | ||
| EG001 | Pneumatic Compression Stockings Arm | Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks. Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) Aspirin | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Bliden | Sinai Center for Thrombosis Research | 4106014795 | kbliden@lifebridgehealth.org |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| D048228 | Intermittent Pneumatic Compression Devices |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004864 | Equipment and Supplies |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
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