Zhang 2014.
Methods |
Study design: Randomised trial Country: China Setting: Single centre; hospital and outpatient clinic; June 2012 and May 2013 Intention‐to‐treat: Yes For the purposes of our analyses we used all participants randomised, as reported by the study authors |
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Participants |
Number randomised: Total n = 40 (extended n = 20; short n = 20) Exclusions post randomisation: Not stated Losses to follow up: None Age mean years (range): Extended 60.1 (37 ‐ 76); short 61.3 (42 ‐ 78) Sex (F/M): Extended 11/9; Short 12/8 Inclusion criteria: All patients admitted to the Center for Bone and Joint Health between June 2012 and May 2013, who were diagnosed with osteonecrosis of the femoral head, scheduled for elective total hip replacement and provided informed consent Exclusion criteria: Had Doppler ultrasound performed 48 hrs prior to the surgery showing DVT; had undergone surgery recently, a history of active major bleeding or a tendency to bleed; had recent use of anticoagulants, antiplatelets or antifibrinogenics; were pregnant or nursing baby or did not take measures to prevent pregnancy; had severe kidney or liver dysfunction or other disease that could interfere with drug metabolism or blood coagulation |
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Interventions |
Treatment: Oral rivaroxaban 10 mg once daily started within 6 ‐ 10 hrs after the surgery for 35 days Control: Oral rivaroxaban 10 mg once daily started within 6 ‐ 10 hrs after the surgery for 7 days followed by no treatment Duration: 35 days post surgery |
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Outcomes |
Primary: Efficacy: haemostatic parameters including thrombin‐antithrombin complexes, prothrombin fragment 1 and 2, D‐dimer and fibrinogen Secondary: DVT Outcomes were recorded pre‐operatively (within 48 hours before surgery) and at 1, 7, and 35 days after surgery |
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Notes |
Funding: Not reported Method of VTE evaluation/confirmation: lower limb ultrasonography |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Using random numbers generated by computer prior to the surgery |
Allocation concealment (selection bias) | Unclear risk | Insufficient information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of blinding of participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for, similar numbers in groups, no missing outcome data |
Selective reporting (reporting bias) | Low risk | All listed outcomes reported on |
Other bias | Low risk | No indication of other bias |
DVT: deep vein thrombosis F: female IU: international unit LMWH: low‐molecular‐weight heparin M: male NSAID: non‐steroidal anti‐inflammatory drug PE: pulmonary embolism post‐op: post‐operatively, after operation pre‐op: prior to operation VAS: visual analogue scale V‐Q: ventilation–perfusion VTE: venous thromboembolism