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 |