Kolluri 2016.
Methods | Randomised, placebo‐controlled, double‐blind study | |
Participants |
Total number of participants: 78 Number of participants allocated to each group: fondaparinux group: 41, placebo group: 37 Number of participants excluded and/or lost to follow‐up: 2 participants in the fondaparinux group and no participants in the placebo group withdrew; all randomised participants were analysed. Inclusion criteria: All patients scheduled to undergo a first or a repeat isolated CABG operation were considered for enrolment in the study. Exclusion criteria
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Interventions |
Fondaparinux (FX): Intervention group received 2.5 mg subcutaneous injections of fondaparinux sodium daily, starting at a mean of 12 ± 2 hours after wound closure or on the morning of the first postoperative day. Second dose was administered at a mean of 24 ± 2 hours after the first dose, and subsequent injections were administered once daily for 9 days or until the patient was discharged from the hospital, whichever happened first. Placebo: Control group received similar amounts of subcutaneous isotonic saline on the same schedule as the intervention group. |
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Outcomes |
Primary study endpoint: composite, up to day 11, of cumulative incidence of all VTE events, defined as symptomatic and asymptomatic DVT, and fatal and non‐fatal pulmonary embolisms Primary safety endpoint: cumulative incidence of major haemorrhages |
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Notes | Use of adjunctive anticoagulative methods: Both groups routinely received graduated compression stockings and/or intermittent pneumatic compression (mechanical antithrombotic prophylaxis). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "This study was conducted in compliance with the Good Clinical Practice guidelines" Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote: "This study was conducted in compliance with the Good Clinical Practice guidelines" Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The control group received similar amounts of subcutaneous isotonic saline on the same schedule as the interventional group" Comment: probably done |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Patients who developed symptomatic DVT or VTE underwent DUS scan of the lower extremities. An independent Data and Safety Monitoring Board monitored the safety of the study." Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Two patients in the fondaparinux group, who withdrew their consent at 3 and 8 days
post enrollment, respectively, did not undergo DUS and were removed from the study. Clinical follow‐ups were complete in 76 patients (97.4%)" Comment: probably done |
Selective reporting (reporting bias) | Low risk | All primary efficacy and safety outcomes listed in the Methods section were reported. Comment: low risk of bias |
Other bias | Low risk | No other bias noted |