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

Parrot 1991.

Study characteristics
Methods Design: RCT, parallel three‐arm, single‐centre study
Setting: university teaching hospital, Dijon, France
Recruitment: recruitment and study dates not reported
Maximum follow‐up: postoperative
Participants 66 participants undergoing aortocoronary bypass surgery were randomly assigned to one of three groups:
Group 1 (control group): N = 22. Mean age = 61 years
Group 2 (intraoperative cell salvage): N = 22. Mean age = 60 years
Group 3 (intraoperative and postoperative cell salvage): N = 22. Mean age = 55 years
There were no differences between groups with respect to age, sex, body surface area, preoperative haematocrit, and bypass duration.
Interventions Group 1 (Control group): control group participants received homologous blood transfusion only.
Group 2 (intraoperative cell salvage): cell salvage group received intraoperative autologous blood. Intraoperative autologous blood consisted of the blood contents of the oxygenator after concentration but without any washing, by the Haemonetics Cell Saver III autologous transfusion system.
Group 3 (intraoperative and postoperative cell salvage): cell salvage group received intraoperative and postoperative autologous blood. Postoperative autologous blood consisted of the mediastinal blood shed during the first 6 hours, into a heparinised drainage system (PLEUR‐EVACA 4005) which was concentrated and washed by a Haemonetics Haemolite system.
Outcomes Outcomes reported: amount of blood re‐transfused from the cell saver, amount of allogeneic blood transfused, number of participants transfused allogeneic blood, adverse events, mortality, blood loss, Hct levels
Notes Transfusion protocol: allogeneic blood transfusions were given if the haematocrit dropped below 20% during bypass, 28% at the end of the procedure, 30% within 24 hours, or if the haemoglobin level was < 10.0 g/dL while on the cardiac surgery ward (8 to 10 days).
Prospective registration status: the study was published prior to 2010.
Ethical approval: it is not clear whether the study was approved by an ethics committee or institutional review board.
Language of publication: English
Study groups: for the purpose of our review, specific groups have been used within our subgroup analyses for cell salvage timing. Group 2 versus Group 1 has been used within the intraoperative cell salvage subgroup. Group 3 versus Group 1 has been used within the intraoperative and postoperative cell salvage subgroup.
Trial funding: not reported
Conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method used to generate allocation sequences was not described.
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 Objective outcome (mortality) unlikely to be influenced by blinding
Blinding of participants and personnel (performance bias)
Subjective: transfusion protocol Low risk Transfusion protocol in place: "All patients received HB ('homologous blood') if their hematocrit dropped below 20% during bypass, 28% at the end of the procedure, 30% within 24 hours, or if their hemoglobin level was < 10 g/dL while on the cardiac surgery ward (8 to I0 days)".
Blinding of participants and personnel (performance bias)
Subjective: all other outcomes High risk No blinding, outcome methods deemed to be at high risk of subjectivity
Blinding of outcome assessment (detection bias)
Objective outcomes: mortality and transfusions Low risk Objective outcome (mortality) unlikely to be influenced by blinding
Blinding of outcome assessment (detection bias)
Subjective outcomes High risk No blinding, outcome methods deemed to be at high risk of subjectivity: criteria for diagnosis of infection and method for measuring blood loss not defined
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Only one person excluded (died). Reason for being excluded is death, should therefore have been kept in (mortality outcomes were not reported)
Selective reporting (reporting bias) Unclear risk No trial registration or published protocol is available to compare
Other bias Unclear risk Some baseline imbalance (group 3 participants are younger, though authors say no statistical difference). No funding or conflicts reported