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Completed

NCT Number: NCT01230658

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

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincent Carmel Bariatric Center of Excellence

Carmel, Indiana, 46032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Thrombotic events - DVT confirmed by doppler guided ultrasound or PE confirmed by CT scan

    Time frame: within 30 days of surgery

  2. 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

  3. Re-admissions to a hospital within 30 days of surgery due to thrombotic or hemorrhagic event

    Time frame: within 30 days of surgery

Sponsors and collaborators

Lead sponsor

Ascension St. Vincent Carmel Hospital

Other

Registry information

Official study title

Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at the St. Vincent Carmel Bariatric Center of Excellence

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 29, 2010
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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