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The purpose of this study is to assess anti-factor Xa concentrations in patients given prophylactic enoxaparin after bariatric surgery.
FDA-approved enoxaparin dosing for venous thromboembolism (VTE) prophylaxis is a fixed-dose regimen irrespective of body mass index (BMI) or actual body weight (ABW). Clinical trials suggest that dosing may be inadequate for obese patients. We plan to assess anti-factor-Xa concentrations in patients who received prophylactic enoxaparin after bariatric surgery.
This prospective study will examine 150 anti-factor Xa concentrations from patients 18 years or older undergoing primary Roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence. Patients receive varying prophylactic enoxaparin regimens at the surgeon's discretion. Anti-factor-Xa concentrations are obtained at steady state.
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| Measure | Description | Time Frame |
|---|---|---|
| Anti-factor Xa concentrations from patients 18 years or older undergoing primary Roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence | Anti-factor Xa concentrations obtained at steady state (3-5 hours after third enoxaparin dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombotic events - DVT confirmed by doppler guided ultrasound or PE confirmed by CT scan | within 30 days of surgery | |
| Hemorrhagic events - defined as a change in hemoglobin greater than 3 G/dL, transfusion of packed red blood cells, endoscopic procedure indicating GI bleeding, or other major bleeding event documented by physician. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 18 years or older undergoing primary roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence.
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| Name | Affiliation | Role |
|---|---|---|
| Karen S Wall, PharmD | Ascension St. Vincent Carmel Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent Carmel Bariatric Center of Excellence | Carmel | Indiana | 46032 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| within 30 days of surgery |
| Re-admissions to a hospital within 30 days of surgery due to thrombotic or hemorrhagic event | within 30 days of surgery |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |