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| Name | Class |
|---|---|
| Stanford University | OTHER |
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Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic & reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic & reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic & reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). Our preliminary data has shown that a fixed, or "one size fits all" dose of enoxaparin, an anticoagulant, can allow a high proportion of patients to have appropriately thinned blood, measured by anti-Factor Xa (aFXa) levels. Patients with adequate aFXa levels are known to have significantly decreased venous thromboembolism risk (VTE), which is desirable. However, 30% of patients who receive fixed dose enoxaparin have blood that is too thin. Patients who are over-anticoagulated are significantly more likely to have ADEs including bleeding requiring return to the operating room, need for blood transfusion, or death. The optimal way to dose enoxaparin to minimize ADEs remains unknown. This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic & reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Dose | Other | Participants will receive 40 mg enoxaparin twice daily |
|
| Variable Dose | Experimental | Participants will receive 0.5mg/kg enoxaparin twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed dose | Drug | Participants will receive 40 mg enoxaparin twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL) | Avoidance of under-anticoagulation (peak aFXa <0.2 IU/mL) | Four hours following third enoxaparin dose |
| Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL) | Avoidance of over-anticoagulation (peak aFXa >0.4 IU/mL) | Four hours following third enoxaparin dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Venous Thromboembolism Events | Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery | 90 days |
| Percentage of Patients With Bleeding Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Puccini, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| University of Utah |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33086312 | Derived | Pannucci CJ, Fleming KI, Varghese TK Jr, Stringham J, Huang LC, Pickron TB, Prazak AM, Bertolaccini C, Momeni A. Low Anti-Factor Xa Level Predicts 90-Day Symptomatic Venous Thromboembolism in Surgical Patients Receiving Enoxaparin Prophylaxis: A Pooled Analysis of Eight Clinical Trials. Ann Surg. 2022 Dec 1;276(6):e682-e690. doi: 10.1097/SLA.0000000000004589. Epub 2020 Oct 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Dose | Participants will receive 40 mg enoxaparin twice daily Fixed dose: Participants will receive 40 mg enoxaparin twice daily |
| FG001 | Variable Dose | Participants will receive 0.5mg/kg enoxaparin twice daily Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fixed Dose | Participants will receive 40 mg enoxaparin twice daily Fixed dose: Participants will receive 40 mg enoxaparin twice daily |
| BG001 | Variable Dose | Participants will receive 0.5mg/kg enoxaparin twice daily Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily |
| 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 | Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL) | Avoidance of under-anticoagulation (peak aFXa <0.2 IU/mL) | Posted | Number | percentage of participants | Four hours following third enoxaparin dose |
|
90 days
Study team performed chart review and made mandatory phone contact with patients at 90 days to identify adverse events.
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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 | Fixed Dose | Participants will receive 40 mg enoxaparin twice daily Fixed dose: Participants will receive 40 mg enoxaparin twice daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Pannucci, MD | University of Utah | 801 581 2121 | christopher.pannucci@hsc.utah.edu |
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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 | Aug 6, 2020 | Aug 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Patients will be randomized into one of two groups (enoxaparin 40mg twice daily or enoxaparin 0.5mg/kg twice daily, rounded to the nearest milligram).
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| Variable dose |
| Drug |
Participants will receive 0.5mg/kg enoxaparin twice daily |
|
Bleeding events requiring alteration in the course of care within 90 days of surgery |
| 90 days |
| Salt Lake City |
| Utah |
| 84132 |
| United States |
| Refused study medication |
|
| Initiated heparin infusion on floor |
|
| Unexpected return to OR |
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| Medication distribution error |
|
| Required epidural placement |
|
| Withdrawal by Subject |
|
| developed acute renal failure |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL) | Avoidance of over-anticoagulation (peak aFXa >0.4 IU/mL) | Posted | Number | percentage of participants | Four hours following third enoxaparin dose |
|
|
|
| Secondary | Percentage of Participants With Venous Thromboembolism Events | Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery | Posted | Number | percentage of patients | 90 days |
|
|
|
| Secondary | Percentage of Patients With Bleeding Events | Bleeding events requiring alteration in the course of care within 90 days of surgery | Posted | Number | percentage of patients | 90 days |
|
|
|
| 1 |
| 151 |
| 0 |
| 151 |
| 0 |
| 151 |
| EG001 | Variable Dose | Participants will receive 0.5mg/kg enoxaparin twice daily Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily | 0 | 144 | 0 | 144 | 0 | 144 |
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| D013927 |
| Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |