Status:
TERMINATED
A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis
Lead Sponsor:
Prairie Education and Research Cooperative
Collaborating Sponsors:
American College of Phlebology
Conditions:
Deep Vein Thrombosis
Coronary Artery Bypass Surgery
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This trial is a prospective, single-center Phase II randomized study to demonstrate the superior efficacy of Fondaparinux Sodium subcutaneous injections in patients undergoing CABG surgery (isolated a...
Detailed Description
Background Information Venous thromboembolism (VTE) following coronary artery bypass graft (CABG) surgery is a formidable risk in view of various predisposing factors including restriction of activit...
Eligibility Criteria
Inclusion
- Subject Inclusion Criteria In order to be enrolled in the study, subjects must meet all of the inclusion criteria as listed below.
- Consecutive patients undergoing isolated or redo isolated CABG
- Patients must provide written informed consent
- Patients must agree to comply with study procedures for the entire length of the study.
- Must be 18 years old or greater.
- Subject Exclusion Criteria Any subject that meets any of the exclusion criteria listed below at baseline will be excluded from study participation.
- Patients with medical history that requires chronic anticoagulation with unfractionated heparin or coumadin or LMWH or heparinoids (i.e. previous DVT, pulmonary embolism, atrial fibrillation, heart valve replacement)
- Patients with contraindications to anticoagulation (coagulopathy e.g, INR\>/=1.5, generalized bleeding disorders, peptic ulcer disease, hemorrhagic or ischemic stroke, etc within last 3 months)
- Patients who are unable to undergo a doppler ultrasound of the lower extremities
- Renal insufficiency (creatinine clearance \< 30 mL/min)
- Patients who have a body weight \< 50 kg
- Patients receiving continuous (indwelling) epidural
- Physician diagnosed acute or chronic hepatic failure
- Pregnancy
- Patients with life expectancy \< 6 months
- Platelet count below 100,000/ mm-3
- History of documented VTE within last 3 months.
- Acute bacterial endocarditis
- Cerebral metastasis or abscess
- Inability to consent
- Refusal by treating physician
Exclusion
Key Trial Info
Start Date :
November 19 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2013
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00789399
Start Date
November 19 2009
End Date
September 21 2013
Last Update
September 8 2022
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