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

NCT01230658 | Completed

• 1 other identifier: STV IRB R2009-111
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

prophylactic enoxaparin; Roux en Y gastric bypass surgery

Outcome Measures

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

  Anti-factor Xa concentrations obtained at steady state (3-5 hours after third enoxaparin dose)

Secondary Outcomes (3)

• 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.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years or older undergoing primary roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence.

You may qualify if:

• Patients 18 years and older undergoing primary roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence

You may not qualify if:

• Receiving anticoagulation therapy prior to surgery (i.e. warfarin)
• Did not receive enoxaparin after surgery

Sponsors & Collaborators

• Ascension St. Vincent Carmel Hospital: lead

Study Sites (1)

St. Vincent Carmel Bariatric Center of Excellence

Carmel, Indiana, 46032, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Karen S Wall, PharmD

  Ascension St. Vincent Carmel Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 14, 2024

Record last verified: 2012-11

Locations

US (1)