Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at St. Vincent Carmel

Completed

• Conditions: Obesity

• Registration Number: NCT01230658
• Lead Sponsor: Ascension St. Vincent Carmel Hospital

Brief Summary

The purpose of this study is to assess anti-factor Xa concentrations in patients given prophylactic enoxaparin after bariatric surgery.

Detailed Description

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-10-29
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2012-11
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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.	within 30 days of surgery
Thrombotic events - DVT confirmed by doppler guided ultrasound or PE confirmed by CT scan	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

Trial Locations

Locations (1)

St. Vincent Carmel Bariatric Center of Excellence; 🇺🇸 Carmel, Indiana, United States