Clinical trial NCT01230658: Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at St. Vincent Carmel
Official title: Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at the St. Vincent Carmel Bariatric Center of Excellence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: prophylactic enoxaparin
Roux en Y gastric bypass surgery
Lead sponsor: Ascension St. Vincent Carmel Hospital
Sponsor class: OTHER
First posted: 2010-10-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Anti-factor Xa concentrations obtained at steady state (3-5 hours after third enoxaparin dose)
Secondary outcomes:
measure: Thrombotic events - DVT confirmed by doppler guided ultrasound or PE confirmed by CT scan
timeFrame: within 30 days of surgery
measure: 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.
timeFrame: within 30 days of surgery
measure: Re-admissions to a hospital within 30 days of surgery due to thrombotic or hemorrhagic event
timeFrame: within 30 days of surgery
Other outcomes:
Locations:
city: Carmel
country: United States
facility: St. Vincent Carmel Bariatric Center of Excellence
state: Indiana
Study officials:
affiliation: Ascension St. Vincent Carmel Hospital
name: Karen S Wall, PharmD
role: PRINCIPAL_INVESTIGATOR
References: