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

Altinel 2007.

Study characteristics
Methods Design: RCT, parallel two‐arm, single‐centre study
Setting: university teaching hospital, Afyon, Turkey
Recruitment: recruitment and study dates not reported
Maximum follow‐up: duration of hospital stay
Participants 32 participants undergoing total knee arthroplasty were randomised to one of two groups:
Study group (Cell salvage/intervention group): N = 16. M:F 0:16. Mean (SD) age 66.9 (9.1). Mean (SD) BMI 32.6 (4.3) kg/m2.
Control group (Control/no cell salvage group): N = 16. M:F 2:14. Mean (SD) age 66.2 (7.1). Mean (SD) BMI 34.3 (8.3) kg/m2.
There was no baseline imbalance between groups with regard to demographic data.
Interventions Study group (Cell salvage/intervention group): cell salvage group (ConstaVac CBCII autotransfusion system) had wound drain connected at the end of the operation. The drain fluid was collected during the first 6 hours. Collected blood was transfused at the end of the 6th hour. Reinfusion was performed using a standard 40 µm blood filter between the collection bag and the intravenous site. After the 6 hours, any blood collected from the reinfusion drain was discarded.
Control group: control group received standard care without autotransfusion.
Outcomes Outcomes reported: number of participants transfused allogeneic blood, blood loss, hospital length of stay, adverse events
Notes Transfusion protocol: allogeneic blood transfusion was given if the haemoglobin level was < 9.0 g/dL.
Prospective registration status: the study was published prior to 2010.
Ethical approval: the study was approved by the Ethics Committee of the Faculty of Medicine, Afyon Kocatepe, Turkey.
Language of publication: English
Trial funding: not reported
Conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Lots drawn
Allocation concealment (selection bias) Unclear risk Method used to conceal treatment allocation was not described
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 Low risk Transfusion protocol in place: if the blood haemoglobin level was below 9 g/dL and there were evident clinical signs of anaemia, patients were given additional homologous blood.
Blinding of participants and personnel (performance bias)
Subjective: all other outcomes Unclear risk Blinding status of participants and personnel is not described
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 Unclear risk One outcome (chest x‐ray evaluation) noted as blinded assessment; suggests the remaining outcomes were not blinded, but not clear
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Unclear patient flow ‐ baseline characteristics suggest 16 per group, but whether this is number randomised, or if all were analysed, is not clear
Selective reporting (reporting bias) Unclear risk No trial registration or published protocol is available to compare
Other bias Unclear risk No mention of funding or conflicts