Newman 1997.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: university teaching hospital, Bristol, Avon, UK Recruitment: recruitment and study dates not reported Maximum follow‐up: duration of hospital stay |
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Participants | 70 consecutive participants undergoing unilateral total knee replacement were randomly allocated to one of two groups: Reinfusion group (Cell salvage/intervention group): N = 35 Homologous transfusion group (Control/no cell salvage group): N = 35 The mean age of participants enroled in study was 72 years. No further demographic data are reported. |
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Interventions |
Reinfusion group (Cell salvage/intervention group): cell salvage group (Dideco 797 reinfusion system) had deep and superficial drains inserted before skin closure and connected to the Dideco 797 reinfusion system which maintains a constant suction of ‐25 mmHg. The drainage collected was mixed with citrate in a ratio of 12:1, filtered during collection and again during reinfusion through a 40 µm filter. No washing took place. Drainage was collected for 6 hours or until 500 mL had accumulated, at which point reinfusion of the unwashed salvaged blood took place. Homologous transfusion group (Control/no cell salvage group): control group had deep and superficial drains inserted before skin closure and connected to a standard Haemovac system which maintains a constant suction of ‐25 mmHg. Autotransfusion was not available to this group. |
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Outcomes | Outcomes reported: amount of blood re‐transfused from cell saver, amount of allogenic blood transfused, number of participants transfused allogeneic blood, adverse events, hospital length of stay | |
Notes |
Transfusion protocol: use of a transfusion protocol is not reported. Prospective registration status: the study was published prior to 2010. Ethical approval: the study was approved by an ethics committee. Language of publication: English Trial funding: none declared Conflicts of interest: Sorin biomedical institutional support declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Method used to generate allocation sequences was adequate: using random number tables |
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 | High risk | The study was unblinded. The criteria for diagnosing infections were not defined. |
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 study was unblinded. The criteria for diagnosing infections were not defined. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants randomised are accounted for in the reported outcomes, ITT analysis |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Low risk | Broadly similar at baseline. Funding declared |