An observational study in Obesity, sponsored by Ascension St. Vincent Carmel Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Ascension St. Vincent Carmel Hospital · Observational
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.
Ascension St. Vincent Carmel Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients 18 years or older undergoing primary roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence.
Exclusion Criteria:
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
Time frame: Anti-factor Xa concentrations obtained at steady state (3-5 hours after third enoxaparin dose)
Thrombotic events - DVT confirmed by doppler guided ultrasound or PE confirmed by CT scan
Time frame: 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.
Time frame: within 30 days of surgery
Re-admissions to a hospital within 30 days of surgery due to thrombotic or hemorrhagic event
Time frame: within 30 days of surgery
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ascension St. Vincent Carmel Hospital