Rosencher 1994.
Study characteristics | ||
Methods |
Design: RCT, parallel three‐arm, single‐centre study Setting: district hospital, Paris, France Recruitment: recruitment and study dates not reported Maximum follow‐up: not reported |
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Participants | 30 participants undergoing total knee arthroplasty were randomised to one of three groups: Ortho‐evac group (Cell salvage/intervention group): N = 10. Mean (SD) age 68 (10) Solcotrans group (Cell salvage/intervention group): N = 10. Mean (SD) age 70 (10) Control group: N = 10. Mean (SD) age 68 (15) The three groups were comparable with regard to age, weight, and height. |
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Interventions |
Ortho‐evac group (Cell salvage/intervention group): cell salvage group (Ortho‐evac system ‐ not containing an anticoagulant) had their autotransfusion system connected to the deep suction drains in the operating room, after skin closure and before tourniquet removal. The salvaged blood was reinfused in the subsequent 6 hours via a 40 µm filter. The volume of collected blood was measured, and allogeneic blood was added as required, to maintain a haematocrit of 30%. The Ortho‐evac system had a 1000 mL capacity. Solcotrans group (Cell salvage/intervention group): cell salvage group (Solcotrans system ‐ not containing an anticoagulant) had their autotransfusion system connected to the deep suction drains in the operating room, after skin closure and before tourniquet removal. The salvaged blood was reinfused in the subsequent 6 hours via a 40 µm filter. The volume of collected blood was measured, and allogeneic blood was added as required, to maintain a haematocrit of 30%. The Solcotrans system had a 500 mL capacity. Control group: control group did not receive autotransfusion. |
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Outcomes | Outcomes reported: amount of blood collected by the cell saver, number of participants transfused allogeneic blood | |
Notes |
Transfusion protocol: allogeneic blood was transfused to maintain a haematocrit of 30%.
Prospective registration status: the study was published prior to 2010. Ethical approval: the study was approved by the ethics committee of the Cochin‐Royal‐Port faculty. Language of publication: French Study groups: for the purpose of our review, we have combined the Ortho‐Evac and Solcotrans groups as the 'cell salvage/intervention' group and compared this to the study control group. 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 unclear. |
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 | 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 | No transfusion protocol in place |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Unclear risk | No information on blinding, no definitions/guidelines for 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 | Unclear risk | No information on blinding, no definitions/guidelines for outcomes |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 30 participants randomised, unclear if all were analysed |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Unclear risk | Funding and conflicts not reported. Authors stated no baseline imbalance, but control group weighed more on average |