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. 2015 Jun 19;2015(6):CD009658. doi: 10.1002/14651858.CD009658.pub2

NCT00789399.

Trial name or title "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"
Methods Prospective, single‐centre, phase II randomised study, single‐blind (investigator)
Participants Consecutive patients aged 18 years or older undergoing isolated or redo isolated CABG
Interventions Fondaparinux (2.5 mg subcutaneous daily) starting 12 +/‐ 2 hours post‐wound closure or the following day in the morning (at the discretion of the cardiothoracic surgeon). The second dose would be administered 24 hours later and the dosing will then be once a day
The group randomised to placebo will receive subcutaneous equivalent volume of isotonic saline at the same time points described above
Patients will receive fondaparinux or placebo for a total of 3 to 9 days post CABG with day 1 being the day of surgery. The drug will be discontinued if the patient is discharged before day 9. If the patient stays for more than 9 days inside hospital, a duplex would be obtained per protocol and further DVT prevention measures would be instituted per the discretion of treating physician
Both groups will receive routine mechanical prophylaxis as determined by the treating physicians
Outcomes Primary outcome: rate of asymptomatic proximal DVT
Secondary outcome: asymptomatic distal DVT
Starting date October 2009
Contact information Cynthia Deitrick (cdeitrick@prairieresearch.com). Principal investigator: Raghu Kolluri
Notes ClinicalTrials.gov identifier: NCT00789399