Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at St. Vincent Carmel
Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at the St. Vincent Carmel Bariatric Center of Excellence
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Indiana
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Carmel, Indiana, Forenede Stater, 46032
- St. Vincent Carmel Bariatric Center of Excellence
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients 18 years and older undergoing primary roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence
Exclusion Criteria:
- Receiving anticoagulation therapy prior to surgery (i.e. warfarin)
- Did not receive enoxaparin after surgery
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
Tidsramme: Anti-factor Xa concentrations obtained at steady state (3-5 hours after third enoxaparin dose)
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Anti-factor Xa concentrations obtained at steady state (3-5 hours after third enoxaparin dose)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Thrombotic events - DVT confirmed by doppler guided ultrasound or PE confirmed by CT scan
Tidsramme: within 30 days of surgery
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within 30 days of surgery
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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.
Tidsramme: within 30 days of surgery
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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
Tidsramme: within 30 days of surgery
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within 30 days of surgery
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Karen S Wall, PharmD, Ascension St. Vincent Carmel Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- STV IRB R2009-111
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