Menges 1992.
| Study characteristics | ||
| Methods |
Design: RCT, parallel three‐arm, single‐centre study Setting: university teaching hospital, Giessen, Germany Recruitment: recruitment and study dates not reported Maximum follow‐up: not reported |
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| Participants | 42 patients undergoing total hip surgery and preoperative plasmaphaeresis (Abbott Autotrans) were randomised to one of three groups: Group 1 (Control/no cell salvage group): N = 12. Mean (SD) age 66.7 (12.7). Mean (SD) weight 67.5 (12.4) kg Group 2 (Autologous blood) (Cell salvage/intervention group): N = 14. Mean (SD) age 55.9 (18.2). Mean (SD) weight 75.2 (9.7) kg Group 3 (Autologous blood and intra‐ and postoperative fresh frozen plasma (FFP)): N = 16. Mean (SD) age 70.6 (7.0). Mean (SD) weight 73.4 (13.1) kg |
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| Interventions |
Group 1 (Control/no cell salvage group): control group for the substitution of blood loss, received in addition to crystalloids and colloids, only allogeneic red blood cells (erythrocyte concentrate). Autotransfusion was not used. Group 2 (Autologous blood) (Cell salvage/intervention group): autotransfusion group for the substitution of blood loss, received in addition to crystalloids and colloids, only autologous packed red blood cells (erythrocyte concentrate) collected by the Autotrans BT 795 P, Dideco system. Group 3 (Autologous blood and intra‐ and postoperative FFP): autotransfusion + FFP group received, additionally, intraoperative and postoperative autologous FFP. NB: study investigated the influence of two different methods of autotransfusion on the intravascular haemostatic system. |
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| Outcomes | Outcomes reported: amount of blood re‐transfused from the cell saver, number of participants transfused allogeneic blood, blood loss | |
| Notes |
Transfusion protocol: participants were transfused if haemoglobin fell below 9.0 g/dL or haematocrit fell below 28%. 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: German Study groups: for the purpose of our review, Group 2 (Autologous transfusion) acts as the intervention group and Group 1 (Control) acts as the 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 | The blinding status of participants and personnel was 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 | The blinding status of outcome assessors was not described |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The total number of participants contributing to the outcome measures is not reported; no info on participant flow, only per‐group baseline data |
| Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
| Other bias | Unclear risk | Baseline imbalance in average age (control mean 10 years older). No info on funding and conflicts |