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

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ClinicalTrials.gov Identifier: NCT01230658
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : November 6, 2012
Sponsor:
Information provided by (Responsible Party):
Karen Wall, 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.

Condition or disease
Obesity

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.

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at the St. Vincent Carmel Bariatric Center of Excellence
Study Start Date : January 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230658


Locations
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United States, Indiana
St. Vincent Carmel Bariatric Center of Excellence
Carmel, Indiana, United States, 46032
Sponsors and Collaborators
Ascension St. Vincent Carmel Hospital
Investigators
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Principal Investigator: Karen S Wall, PharmD Ascension St. Vincent Carmel Hospital
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Responsible Party: Karen Wall, Pharmacist, Ascension St. Vincent Carmel Hospital
ClinicalTrials.gov Identifier: NCT01230658    
Other Study ID Numbers: STV IRB R2009-111
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: November 6, 2012
Last Verified: November 2012
Keywords provided by Karen Wall, Ascension St. Vincent Carmel Hospital:
prophylactic enoxaparin
Roux en Y gastric bypass surgery