Teetzman 2014.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐group, single‐centre study Setting: regional hospital in Norway Recruitment: December 2009 to December 2012 (study dates) Maximum follow‐up: duration of hospital stay |
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Participants | 164 participants undergoing elective hip surgery were randomised to one of two treatment groups: Group 1 (Autotransfusion of autologous blood) (cell salvage/intervention group): N = 74. Mean age 73 Group 2 (Allo‐transfusion group) (control/no cell salvage group): N = 90. 87 participants were included in the final analysis after one perioperative death and erroneous administration of autologous blood to two participants. Mean age of the included 87 participants was 73. The authors state that there were no significant differences in baseline characteristics, though the percentages show differences in multiple domains (gender, medication for blood pressure, medications affecting platelets). |
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Interventions |
Group 1 (Autotransfusion of autologous blood) (cell salvage/intervention group): participants in the autologous transfusion group underwent cell salvage using the Sangvia Blood Salvage System. Blood was collected intra‐ and postoperatively. The maximum collection time was 6 hours and maximum collection volume was 1500 mL. Autologous transfusion was routinely given to participants in this group unless there was a failure in the collection process or the sample was insufficient (< 200 mL). The salvaged blood was not washed prior to reinfusion. Group 2 (Allo‐transfusion group) (control/no cell salvage group): the control group received standard perioperative care and allogeneic blood transfusions, as required, according to the clinical judgement of the doctor on duty. |
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Outcomes |
Primary outcome: difference in infection rates between groups Secondary outcomes: volume of blood transfused, transfusion reactions, length of hospital stay, number of days on antibiotic treatment, days with body temperature > 38C |
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Notes |
Transfusion protocol: allogeneic transfusions were prescribed by the doctor on duty according to clinical judgement. Prospective registration status: the study was retrospectively registered with a trials registry (NCT01725724). The study start date was 3 years before registration. Ethical approval: the study was approved by the regional ethics committee for Stord Hospital, Helse Fonna HF, Norway. 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 | The randomisation method is not described |
Allocation concealment (selection bias) | Unclear risk | The method of allocation concealment is not described |
Blinding of participants and personnel (performance bias) Objective outcome: mortality | Low risk | Objective outcome (mortality) unlikely to be influenced by blinding |
Blinding of participants and personnel (performance bias) Subjective: transfusion protocol | High risk | No transfusion protocol: all allogeneic transfusions were prescribed by the doctor on duty according to a clinical judgement. |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | High risk | No blinding of personnel, and multiple outcomes have no clearly defined decision‐making/diagnostic criteria |
Blinding of outcome assessment (detection bias) Objective outcomes: mortality and transfusions | Low risk | Objective outcome (mortality) unlikely to be influenced by blinding |
Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | No blinding of outcome assessors, but infection outcome has clearly‐defined criteria that minimises risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Low number of dropouts, but all in the control group: 3 participants were excluded from the control group following randomisation: 1 secondary to perioperative mortality and 2 due to erroneous administration of autologous blood. Imbalance in group size, no info on participant flow, so it is unclear why this is the case (whether more participant were excluded or crossed over) |
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 state no significant difference in baseline characteristics, though the percentages show differences in multiple domains (gender, medication for blood pressure, medications affecting platelets). |