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

NCT ID: NCT01230658

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascension St. Vincent Carmel Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Wall

Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen S Wall, PharmD

Role: PRINCIPAL_INVESTIGATOR

Ascension St. Vincent Carmel Hospital

Locations

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St. Vincent Carmel Bariatric Center of Excellence

Carmel, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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STV IRB R2009-111

Identifier Type: -

Identifier Source: org_study_id

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