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. 2023 Sep 8;2023(9):CD001888. doi: 10.1002/14651858.CD001888.pub5

Newman 1997.

Study characteristics
Methods Design: RCT, parallel two‐arm, single‐centre study
Setting: university teaching hospital, Bristol, Avon, UK
Recruitment: recruitment and study dates not reported
Maximum follow‐up: duration of hospital stay
Participants 70 consecutive participants undergoing unilateral total knee replacement were randomly allocated to one of two groups:
Reinfusion group (Cell salvage/intervention group): N = 35
Homologous transfusion group (Control/no cell salvage group): N = 35
The mean age of participants enroled in study was 72 years. No further demographic data are reported.
Interventions Reinfusion group (Cell salvage/intervention group): cell salvage group (Dideco 797 reinfusion system) had deep and superficial drains inserted before skin closure and connected to the Dideco 797 reinfusion system which maintains a constant suction of ‐25 mmHg. The drainage collected was mixed with citrate in a ratio of 12:1, filtered during collection and again during reinfusion through a 40 µm filter. No washing took place. Drainage was collected for 6 hours or until 500 mL had accumulated, at which point reinfusion of the unwashed salvaged blood took place.
Homologous transfusion group (Control/no cell salvage group): control group had deep and superficial drains inserted before skin closure and connected to a standard Haemovac system which maintains a constant suction of ‐25 mmHg. Autotransfusion was not available to this group.
Outcomes Outcomes reported: amount of blood re‐transfused from cell saver, amount of allogenic blood transfused, number of participants transfused allogeneic blood, adverse events, hospital length of stay
Notes Transfusion protocol: use of a transfusion protocol is not reported.
Prospective registration status: the study was published prior to 2010.
Ethical approval: the study was approved by an ethics committee.
Language of publication: English
Trial funding: none declared
Conflicts of interest: Sorin biomedical institutional support declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Method used to generate allocation sequences was adequate: using random number tables
Allocation concealment (selection bias) Unclear risk Method used to conceal treatment allocation was unclear
Blinding of participants and personnel (performance bias)
Objective outcome: mortality Low risk No objective outcomes reported (mortality unlikely to be affected by blinding if reported in future publications)
Blinding of participants and personnel (performance bias)
Subjective: transfusion protocol High risk No transfusion protocol in place
Blinding of participants and personnel (performance bias)
Subjective: all other outcomes High risk The study was unblinded. The criteria for diagnosing infections were not defined.
Blinding of outcome assessment (detection bias)
Objective outcomes: mortality and transfusions Low risk No objective outcomes reported (mortality unlikely to be affected by blinding if reported in future publications)
Blinding of outcome assessment (detection bias)
Subjective outcomes High risk The study was unblinded. The criteria for diagnosing infections were not defined.
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants randomised are accounted for in the reported outcomes, ITT analysis
Selective reporting (reporting bias) Unclear risk No trial registration or published protocol is available to compare
Other bias Low risk Broadly similar at baseline. Funding declared