Elawad 1991.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: university teaching hospital, Malmo, Sweden Recruitment: recruitment and study dates not reported Maximum follow‐up: 24 hours postoperatively |
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Participants | 40 participants undergoing primary total hip arthroplasty were randomly allocated to one of two groups: Autologous group (Cell salvage/intervention group): N = 20. M:F 9:11. Mean (range) age 68 (59 to 89) Homologous group (Control/no cell salvage group): N = 20. M:F 8:12. Mean (range) age 74 (48 to 89) The authors do not state whether there were any between‐group differences at baseline. |
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Interventions |
Autologous group (Cell salvage/intervention group): cell salvage group received autologous blood processed intraoperatively by a cell saver device (Electromedic Autotrans AT1000 autotransfusion system). Blood was retrieved from the operative field with a double lumen suction catheter. The blood was immediately anticoagulated with sodium citrate. Larger debris was removed by a 240 µm filter in the cardiotomy reservoir. The filtered blood was pumped into a bowl centrifuge and washed with 1500 mL of saline. The supernatant was discarded. The erythrocyte concentrate was pumped into a reinfusion bag and then reinfused into the patient. Homologous group (Control/no cell salvage group): control group received allogeneic blood and no autotransfusion. |
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Outcomes | Outcomes reported: amount of allogeneic units transfused, number of participants receiving allogeneic blood, complications, blood loss | |
Notes |
Transfusion protocol: the indications for blood transfusion were the same in both groups. Intraoperatively, blood was given according to the anaesthetist’s decision. Postoperatively, a transfusion was given if the haemoglobin was < 85 g/L or if there were symptoms of anaemia. 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 Trial funding: not reported Conflicts of interest: not reported |
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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 | Does not state whether sealed envelopes are also opaque |
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 | Transfusion protocol in place but intraoperative transfusion according to clinician decision: intra‐op high ROB as decided by the clinician. Transfusion protocol post‐op only: "The indications for blood transfusion were the same in both groups. Intraoperatively, blood was given according to the anesthetist’s decision. Postoperatively, a transfusion was given if the hemoglobin was < 85 g/L or if there were symptoms of anemia (Grindon et al. 1985)" |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | High risk | Variable techniques for blood loss measurement; no description for other outcomes |
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 blinding status of participants and personnel was not described but transfusion decisions according to clinician preference intraoperatively |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant was excluded due to logistical failures |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Unclear risk | Baseline imbalance marginal (age range included younger patients in control group but mean was similar). Funding and conflicts not reported |