Marberg 2010.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: university teaching hospital, Gothenburg, Sweden Recruitment: September 2006 to May 2007 Maximum follow‐up: duration of hospital stay |
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Participants | 80 consecutive participants with stable angina pectoris, scheduled for CABG were randomised to either autotransfusion or no‐autotransfusion of mediastinal shed blood. Autotransfusion group (Cell salvage/intervention group): N = 39. Mean (SD) age 66 (10). M:F 30:9. Mean (SD) BMI 27 (4). No autotransfusion group (Control/no cell salvage group): N = 38. Mean (SD) age 68(8). M:F 29:9. Mean (SD) BMI 28 (3). There was a between‐group difference in left ventricular ejection fraction (LVEF) at baseline. |
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Interventions |
Autotransfusion group (Cell salvage/intervention group): participants received autotransfusion of all mediastinal shed blood in the first 12 hours postoperatively. Cardiotomy suction blood was continuously re‐transfused without cell salvage during CPB. No autotransfusion group (Control/no cell salvage group): participants avoided all autotransfusion (mediastinal shed blood was discarded). Cardiotomy suction blood was continuously re‐transfused without cell salvage during CPB. |
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Outcomes | Outcomes reported: postoperative bleeding volume during the first 12 postoperative hours, transfusion requirements | |
Notes |
Transfusion protocol: “Transfusion triggers were predefined in the local clinical protocol. RBC transfusions were given when blood haemoglobin level decreased to < 80 g/L. Platelets were transfused in patients with ongoing bleeding > 300 mL/hr and platelet count < 50 x 109/L, or suspected or confirmed platelet dysfunction. Plasma was transfused in patients with ongoing bleeding > 200 mL/hr and signs of impaired coagulation on thrombo‐elastometry. The final decision regarding transfusion was always made by the attending physician.” Prospective registration status: the study was not prospectively registered with a trials registry. Ethical approval: the study was approved by the Regional Research Ethics Committee for Sahlgrenska University Hospital, Gothenberg, Sweden. Language of publication: English Trial funding: the study was supported by the Swedish Heart and Lung Foundation and Sahlgrenska University Hospital 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 | Randomisation sequence method not stated |
Allocation concealment (selection bias) | Unclear risk | While the envelopes used were unmarked, it is not described whether allocation concealment was achieved by using opaque envelopes. |
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 | Authors provide transfusion protocol but state that in all cases, the final decision to transfuse was made by attending physician, which indicates scope for deviation from protocol. |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | High risk | Lack of blinding of participants/personnel during procedure/postoperative care could affect outcomes such as blood loss/reoperation for rebleed (this trigger has not been defined by authors). |
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 | Unclear risk | Blinding status unclear |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants randomised within the study are accounted for in the outcome data. |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Low risk | No obvious baseline imbalance. Funding reported (no pharmaceutical funding: the study was supported by the Swedish Heart and Lung Foundation and Sahlgrenska University Hospital). Conflicts of interest not reported |