Zhang 2008.
Study characteristics | ||
Methods |
Design: RCT, parallel three‐arm, single‐centre hospital Setting: regional hospital, Zhenhai, Ningbo, China Recruitment: March 2005 to December 2006 Maximum follow‐up: 48 hours postoperatively |
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Participants | 60 participants undergoing orthopaedic procedures were randomly allocated to one of three groups: Group 1(Platelet‐rich plasmapheresis + autotransfusion group): n = 20 Group 2(Simple autologous blood) (cell salvage/intervention group): n = 20 Group 3 (Untreated group) (control/no cell salvage group): n = 20 Demographic data not reported for each trial arm. |
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Interventions |
Group 1(Platelet‐rich plasmapheresis + autotransfusion group): platelet‐rich plasmapheresis group received platelet‐rich plasma (PRP)and autotransfusion with the use of the Haemonetics Cell Saver 5 system. Group 2(Simple autologous blood) (cell salvage/intervention group): autotransfusion group received intraoperative autotransfusion of shed blood using the Haemonetics Cell Saver 5 system. Group 3 (Untreated group)(control/no cell salvage group): control group received standard care without PRP and autotransfusion. |
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Outcomes | Outcomes reported: number of participants transfused allogeneic blood, blood loss | |
Notes |
Transfusion protocol: the use of a transfusion protocol is not reported within the translated article. Prospective registration status: the study was published prior to 2010. Ethical approval: it is unclear whether the study was approved by an ethics committee or institutional review board. Language of publication: Chinese Study groups: for the purpose of our review, the comparison of interest is Group 2 (autotransfusion only) versus Group 3 (untreated 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 (translation). |
Allocation concealment (selection bias) | Unclear risk | Method used to conceal treatment allocation was unclear (translation). |
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 (translation) |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Unclear risk | No protocols; no blinding (translation) |
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 protocols; no blinding (translation) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 60 analysed, but no info on number randomised, or any protocol violations (translation) |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Unclear risk | No baseline imbalance (there was no significant difference in age, weight, gender composition amongst the 3 groups (P > 0.05)). No mention of funding or conflicts of interest in translation |