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. 2012 May 16;2012(5):CD007338. doi: 10.1002/14651858.CD007338.pub3

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:
  1. Living donor liver transplantation (donor retrieval)

  2. Normal livers

  3. Age 18 to 65 years.


Exclusion criteria:
  1. Hypertension or hypotension

  2. Haemoglobin <11 g/dL within a week prior to the operation

  3. INR > 1.5

  4. Bleeding time > 5 minutes

  5. Unstable haemodynamics during surgery.

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 Whole blood equal to 0.7% of body weight was withdrawn before start of hepatic parenchymal division and stored for re‐transfusion after graft procurement.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.
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.
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)."