Hashimoto 2007.
Methods | Randomised clinical trial. | |
Participants | Country: Japan.
Number randomised: 80.
Post‐randomisation drop‐outs: 1 (1.3%) (see notes).
Median age: 30 and 37 years in the two groups.
Females: 30 (38.0%).
Major liver resections: 77 (97.5%).
Cirrhotic livers: 0 (0%). Inclusion criteria:
Exclusion criteria:
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Interventions | Participants were randomly assigned to two groups. Group 1: autologous blood donation (n = 40). Group 2: control (n = 39) (See notes). Further details of intervention: Whole blood equal to 0.7% of body weight was withdrawn before start of hepatic parenchymal division and stored for re‐transfusion after graft procurement. Other details: Vascular occlusion: intermittent PTC. Method of parenchymal transection: CUSA. Management of raw surface: not stated. Other co‐interventions to decrease blood loss: none reported. |
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Outcomes | The outcome measures were mortality, transfusion requirements, peri‐operative morbidity, hospital stay, blood loss and liver function tests. | |
Notes | One patient from control group in whom the surgery was cancelled because of asthmatic attack was excluded from analysis. Authors replied to questions related to mortality and transfusion requirements in November 2008. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The participants were randomly assigned in the operating room to either the blood salvage group (BS group) or a control group using a minimization method with 3 stratifying factors: age....." |
Allocation concealment (selection bias) | Low risk | Quote: "The participants were randomly assigned in the operating room to either the blood salvage group (BS group) or a control group using a minimization method with 3 stratifying factors: age....." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "the surgical team and participants were blinded to the data throughout the study period." Comment: The anaesthetists were not blinded to the groups. This could have resulted in different managements for the two groups. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "the surgical team and participants were blinded to the data throughout the study period." Comment: The anaesthetists were not blinded to the groups. This could have resulted in different managements for the two groups. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: There was one post‐randomisation drop‐out. This patient did not undergo surgery and none of the outcomes could be measured or reported. This was not due to the treatment effect. |
Selective reporting (reporting bias) | High risk | Comment: Important outcomes such as liver failure were not reported. |
Free of vested interest bias? | Low risk | Quote: "Supported by a grant from the Kanae Foundation for Life & Socio‐medical Science, a grant from the Public Trust Surgery Research Fund, a grant from the Japanese Clinical Oncology Fund, a grant from the Public Trust Haraguchi Memorial Cancer Research Fund in Japan, and a Grant‐in‐Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan (No. 18790955)." |