Adalberth 1998.
Study characteristics | ||
Methods |
Deisgn: RCT, parallel three‐arm, single‐centre study Setting: university teaching hospital, Uppsala, Sweden Recrutiment: recruitment and study dates are not reported Maximum follow‐up: duration of hospital stay |
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Participants | 90 participants undergoing primary total knee arthroplasty were randomised to one of three groups: No drain group: N = 30. M:F 11:13. Mean (95% CI) age 70 (67 to 74) Solcotrans drain group (Cell salvage/intervention group): N = 30. M:F 4:20. Mean (95% CI) age 71 (69 to 74) Standard (Redon) drain group (Control/no cell salvage group): N = 30. M:F 9:16. Mean (95% CI) age 72 (69 to 75) Of the 90 participants included in the study, 73 remained for analysis. Patients with DVT, drainage failure, lost study values, or those given NSAIDs were excluded. For the purpose of our analysis, we included data from the Solcotrans drain group as the intervention group and the Standard (Redon) drain group as the control group. |
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Interventions |
No drain group: no drain was used. Solcotrans drain group: Solcotrans autotransfusion system collected blood for 6 hours or until the unit was full. Acid citrate dextrose‐anticoagulant (ACD‐A) was not added to the collection unit. Continuous suction was applied at 20 cm H2O. Drains were maintained for 24 hours postoperatively. Standard (Redon) drain group: a standard disposable closed suction drainage system (Redon) was used with two standard drains maintained for 24 hours postoperatively. |
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Outcomes | Outcomes reported: number of participants transfused allogeneic blood, blood loss, hospital length of stay, Hb and Hct levels | |
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 at Uppsala University Hospital. 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 | Randomisation process not described |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes were used to conceal treatment allocation, but doesn't mention opaqueness of envelopes |
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: allogeneic blood transfusion was given if the haemoglobin level was < 9.0 g/dL. |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | High risk | All outcomes lack clear guidelines |
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 | All outcomes lack clear guidelines |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 20% attrition rate, even across the three groups; those excluded were due to adverse events (unclear if AEs due to intervention or if DVT etc. noted at baseline and were incorrectly included) |
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 |