Wu 2006.
Methods | Randomised clinical trial | |
Participants | Country: Taiwan
Number randomised: 217
Postrandomisation dropouts: 3 (1.4%)
Revised sample size: 214
Average age: 60 years
Women: 57 (26.6%)
Number of cirrhotics: 110 (51.4%)
Number of major liver resections: 38 (17.8%)
Number of right hepatectomies: 18 (8.4%)
Follow‐up (months): until discharge
Further details of methods of liver resection 1. Vascular occlusion: varied 2. Parenchymal transection: clamp‐crush method 3. Fibrin glue: not stated 4. Pharmacological methods: factor being randomised 5. Cardiopulmonary methods: not stated 6. Autologous transfusion: not stated Inclusion criteria: patients undergoing liver resections |
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Interventions | Participants were randomly assigned to 2 groups. Group 1: tranexamic acid (n = 108) Group 2: control (n = 106) Tranexamic acid: 500 mg just before the surgery followed by 250 4 times a day for 3 d | |
Outcomes | The outcomes reported were: short‐term mortality, number of serious adverse events, proportion of people with any adverse events, number of adverse events, operative blood loss, proportion of people requiring blood transfusion, length of hospital stay, and operating time. | |
Notes | Reasons for postrandomisation dropouts: liver resection not completed because of presence of more extensive disease | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: this information was not available. |
Allocation concealment (selection bias) | Unclear risk | Quote: "The randomization was double‐blinded in a sealed envelope". Comment: further details of sealed envelope method were not available. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Neither surgeons nor medical staffs knew whether patients were enrolled in group A or group B ". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Neither surgeons nor medical staffs knew whether patients were enrolled in group A or group B ". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: although there were 3 postrandomisation dropouts, this was because liver resection could not be carried out. |
Selective reporting (reporting bias) | High risk | Comment: severity of morbidity was not reported. |
Vested interest bias | Unclear risk | Quote: "Supported in part by a grant from National Science Council, Taiwan (No. 92‐2314‐B‐075A‐006) ". Comment: only part of the funding information was available. |
Other bias | Low risk | Comment: no other bias |