Shen 2014.
| Methods | Randomised controlled study | |
| Participants |
Total number of participants enrolled: 121 Number of participants allocated to each group: fondaparinux (FX) group: 59, nadroparin calcium (NA) group: 57 Number of participants excluded and/or lost to follow‐up: not mentioned Inclusion: clinical diagnosis of oesophageal carcinoma and planned for oesophagectomy; clinical diagnosis of lung carcinoma and planned for lung resection; general anaesthesia combined with epidural anaesthesia Exclusion: blood clotting dysfunction before surgery; anticoagulating or antiplatelet history before surgery; low blood platelet count; haemorrhagic disease; cerebral haemorrhage; cerebral, spinal or ophthalmologic operation history; peptic ulcer; bleeding > 400 mL during operation; bleeding > 100 mL/h after operation; blood transfusion during or after operation; severe renal or liver dysfunction; severe hypertension |
|
| Interventions |
FX: 2.5 mg IH once daily after operation NA: nadroparin calcium 4100 AxaIU IH once daily after operation |
|
| Outcomes | Primary efficacy outcomes: VTE events and drainage volume | |
| Notes | Use of adjunctive anticoagulative methods: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Study authors confirmed that they used the computer‐derived randomisation table. Comment: low risk of bias |
| Allocation concealment (selection bias) | Low risk | Study authors confirmed that they used the computer‐derived randomisation table. Comment: low risk of bias |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The study publication did not clearly describe methods of blinding, and communication with study authors did not provide further information. Comment: unclear |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study authors confirmed that outcome assessors did not know the group information. Comment: low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "A total of 121 patients were enrolled in this study, and 116 eligible patients were randomly assigned (Group H: 57 patients; Group F: 59 patients)" Comment: low risk of bias |
| Selective reporting (reporting bias) | Unclear risk | Results of VTE rates were reported, but the number of events was not clearly reported. Drainage volumes of study participants were reported. |
| Other bias | Low risk | No risk of other bias was identified. |