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| Name | Class |
|---|---|
| American Urological Association | OTHER |
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The goal of this randomized trial is to compare bladder cancer patient experiences taking prophylactic anticoagulation at home after surgery to remove their bladder. The main questions it aims to answer are:
Participants will be randomized to receive a prescription for either enoxaparin or apixaban which they will then fill themselves and self-administer at home until post-operative day 30. They will receive phone calls from study coordinators at days 30 and 90 to complete questionaries over the phone to assess trial outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin | Active Comparator | Participants randomized to receive script for prophylactic dose of enoxaparin. Dosing will be done based on clinical providers (pharmacists) according to usual care. Participants will fill the script themselves. |
|
| Apixaban | Experimental | Participants randomized to receive script for prophylactic dose of apixaban. Dosing will be done based on clinical providers (pharmacists) according to usual care. Participants will fill the script themselves. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apixaban | Other | Participants will be randomized to receive a prescription for prophylactic apixaban |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | proportion of days covered | Day of discharge to post-operative day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | patient out of pocket cost to fill their VTE prophylaxis prescription | Day of discharge to post operative day 90 |
| Satisfaction as measured by 2. National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katharine F Michel, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2024 | Feb 2, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2024 | Jan 23, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| enoxaparin | Other | Participants will be randomized to receive a prescription for prophylactic enoxaparin |
|
patient satisfaction with their VTE prophylaxis drug |
| Day of discharge to post-operative day 30 |
| Reasons for non-adherence | patient-reported issues with adherence | Day of discharge to post-operative day 30 |
| VTE rate | rate of venous thromboembolism events | Day of discharge to post-operative day 90 |
| Bleeding rate | rate of major and minor bleeding events | Day of discharge to post-operative day 90 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002241 |
| Carbohydrates |