L‐8635.
| Methods | Randomised, open label, evaluator‐blinded | |
| Participants |
Total number of participants: 51 Number of participants allocated to each group: fondaparinux (FX) group: 28, enoxaparin (EN) group: 23 Number of participants excluded and/or lost to follow‐up: FX group: 4 (0 adverse events, 0 lack of efficacy, 4 other reasons), EN group: 1 (1 adverse event, 0 lack of efficacy, 0 other reasons) Inclusion: Patients ≥ 20 years of age scheduled for primary elective total knee replacement surgery were included in the study. Exclusion: Patients were excluded if they had leg oedema, peripheral vascular disease, diabetes with peripheral neuropathy or any condition likely to increase the risk of bleeding. |
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| Interventions | FX: 2.5 mg FX 2.5 sc once daily for 7 days. First postoperative dose was given ≥ 6 hours after closure of the surgical wound, and the second dose 18 to 24 hours after the first dose. Thereafter, daily at 8 PM ± 2 hours for 5 days. EN: 40 mg EN sc once daily for 7 days. First dose was given 12 hours before surgery, and thereafter daily for 7 days. | |
| Outcomes |
Primary efficacy outcome: incidence of occurrence of VTE events (DVT, as determined by clinical assessment and compression Doppler) up to day 10 Primary safety outcome: Major bleeding, minor bleeding, no bleeding, adverse events (AEs) and serious adverse events (SAEs) were monitored from day 0 up to day 37. |
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| Notes | Use of adjunctive anticoagulative methods: no mention of use of any adjunctive anticoagulative method | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomized, open label" Comment: probably done, as earlier reports from the same company clearly describe use of random sequences |
| Allocation concealment (selection bias) | Low risk | Quote: "Multicentre, randomised, open‐label study" Comment: probably done, as most earlier multi‐centre RCT reports clearly mentioned that studies of the same medicine organised by the same company were centrally randomised |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "open‐label" study Comment: probably not done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "evaluator‐blind" Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 85.7% and 95.7% of participants in the 2 study groups completed medication. Comment: low risk of bias |
| 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 | Unclear risk | Company sponsored |