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 |