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Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients

NCT00894283 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2019-06-07

No results posted yet for this study

Summary

This pilot study is designed to determine the feasibility of conducting a randomized clinical trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®) twice daily with respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after bariatric surgery in obese patients.

Conditions

Interventions

DRUG

Enoxaparin

Patients will receive enoxaparin 40mg subcutaneously twice daily during perioperative period of bariatric surgery. Patients will be encouraged to ambulate and compression stockings while in bed.

DRUG

Fondaparinux

Fondaparinux 5mg subcutaneously 6 hours following surgery, fondaparinux 5mg subcutaneously once daily during hospitalization. Patients will be encouraged to ambulate and compression stockings while in bed.

Sponsors & Collaborators

Principal Investigators

  • Kimberley E Steele, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894283 on ClinicalTrials.gov