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. 2016 Oct 31;2016(10):CD005134. doi: 10.1002/14651858.CD005134.pub3

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
  • Long‐term anticoagulation with unfractionated or low molecular weight heparin, coumadin or heparinoids

  • Contraindications to anticoagulation

  • Creatinine clearance < 30 mL/min

  • Body weight < 50 kg

  • Presence of indwelling epidural catheter

  • Hepatic failure

  • Pregnant state

  • Life expectancy < 6 months

  • Platelet count < 100,000/mm3

  • Whole blood haemoglobin concentration < 9 g/dL

  • Venous thromboembolism documented within past 3 months

  • Acute bacterial endocarditis

  • Cerebral metastasis or abscess

  • History of heparin‐induced thrombocytopaenia

  • Presence of acute deep venous thrombosis on preoperative duplex ultrasonography of lower extremities

  • Inability to undergo venous duplex of lower extremities

  • Inability to consent

  • Refusal by treating physician

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.
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
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