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. 2023 Oct 24;2023(10):CD013584. doi: 10.1002/14651858.CD013584.pub2

Chen 2016.

Study characteristics
Methods Single‐centre, prospective, randomised, controlled study with a 1:1 allocation ratio
Run‐in period: July 2014 to March 2015
Registration date: not specified
Number of study centres and locations: single centre; State Key Laboratory of Cardiovascular Disease and the Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China
Participants Sixty participants
Mean age: 47 years vs 47 years
Sex (female/male ratio): 18/42
High‐risk patients (total arch replacement)
Inclusion criteria: patients receiving aortic arch replacement with DHCA, both sexes
Exclusion criteria: reoperation, anti‐Plt drug treatment within 7 days before the operation, infectious diseases, and chronic renal or hepatic dysfunction
Interventions Intervention: circuit coating (coated with human albumin by circulating the prime for 5 minutes at 4 L/min before CPB); study group (circulating the prime with 40 g albumin for 5 minutes before CPB)
Control: noncoating circuit; control group (receiving 40 g human albumin 5 minutes after the initiation of CPB)
Outcomes Time points: baseline, after anaesthesia induction and before CPB (T1), and 10 min after heparin reversal before any blood product transfusion (T2)
Outcomes: MA at 10 min after heparin reversal before any blood product transfusion; other r‐TEG parameters; complete blood count containing HB, Plt, and WBC; coagulation test involving PT, APTT, and fibrinogen; inflammatory cytokines, comprising IL‐1, IL‐6, IL‐10, TNF‐α, and PAF; the amount of bleeding and transfusion data
Blood samples were taken from the arterial line at the following time points:

  1. after anaesthesia induction;

  2. before aortic cannulation;

  3. 10 minutes after aortic cross‐clamp release;

  4. 5 minutes after protamine sulphate administration;

  5. 4 hours after protamine sulphate administration; and

  6. 24 hours after protamine sulphate administration.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random number list
Allocation concealment (selection bias) High risk No details given around concealment of allocation
Blinding of participants and personnel (performance bias)
All outcomes Low risk The attending medical team was blinded to the randomisation. Perfusionist was not blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk No clear details given
Incomplete outcome data (attrition bias)
All outcomes Low risk No trial group changes, no withdrawals, and no losses to follow‐up were reported, but no ITT analysis. Data from all the participants were included in the final analysis.
Selective reporting (reporting bias) Low risk All expected outcomes were reported.
Other bias Low risk No funding was disclosed or reported.