Gäbel 2013a.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: university teaching hospital, Gothenburg, Sweden Recruitment: recruitment and study dates not reported Maximum follow‐up: 24 hours postoperatively |
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Participants | 34 participants undergoing elective CABG for stable angina were randomised to one of two groups: Retransfusion group (Cell salvage/intervention group): N = 15. Mean (SD) age 66 years (8). M:F 11:4. Mean (SD) BMI 27 (4). No retransfusion group (Control/no cell salvage group): N = 15. Mean (SD) age 66 years (8). M:F 12:3. Mean (SD) BMI 27 (4). There was between‐group difference in time spent on the Extracorporeal Circuit (ECC). |
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Interventions |
Retransfusion group (Cell salvage/intervention group): all cardiotomy suction blood was collected in a separate closed uncoated cardiotomy reservoir. Participants in intervention group had re‐transfusion of cardiotomy suction blood (no processing) prior to weaning from cardiopulmonary bypass (CPB). No re‐transfusion group (Control/no cell salvage group): all cardiotomy suction blood was collected in a separate closed uncoated cardiotomy reservoir. Participants in the control group were randomised to no re‐transfusion of cardiotomy suction blood prior to weaning from CPB. |
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Outcomes | Outcomes reported: postoperative bleeding, amount of transfused red cells, amount of transfused plasma, amount of transfused platelets, MACE as defined by myocardial infarction or any other evidence of thrombotic event | |
Notes |
Transfusion protocol: red blood cell transfusions were given when blood haemoglobin levels decreased to < 80 g/L or if the patient had symptomatic anaemia. Prospective Registration Status: the study was not prospectively registered with a trial registry. Ethical approval: the study received ethical approval from the Research Ethics Committee of the Medical Faculty, University of Gothenburg, Gothenburg, Sweden. Language of publication: English Trial funding: Västra Götaland region (ALF/LUA grant 146281 to AJ), Gothenburg Medical Society (4201 to JG) and The Swedish Heart and Lung Foundation (20090488 to AJ) Conflicts of interest: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation methodology not described |
Allocation concealment (selection bias) | Unclear risk | Not known whether envelopes are opaque and sealed |
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 | Low risk | Transfusion protocol in place: RBC transfusions were given when blood haemoglobin level decreased to < 80 g/L, or if the patient had symptomatic anaemia. |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Low risk | All trial personnel other than the research coordinator and perfusionist were blinded to treatment allocation. |
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 | Low risk | All trial personnel other than the research coordinator and perfusionist were blinded to treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | N used for analysis is unclear; 4 participants were excluded following randomisation (1 due to pericardial adhesions, 1 due to overseen treatment with clopidogrel, 1 due to < 100 mL cardiotomy suction blood, and 1 due to technical error intraoperatively). A priori sample size calculation deemed that 30 participants were needed for the study, which was still achieved. |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Low risk | Funding reported and no conflicts reported. Baseline imbalance in ECC time present but unlikely to impact outcomes |