Scrascia 2012.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: university teaching hospital, Bari, Italy Recruitment: September 2009 to March 2010 Maximum follow‐up: duration of hospital stay |
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Participants | 34 participants undergoing first‐time, elective CABG surgery on cardiopulmonary bypass (CPB) were randomised to one of two groups: Cell salvage group (Cell salvage/intervention group): N = 17. M:F 8:9. Mean (SD) age 71 (8). Mean (SD) BMI 27 (4) Control group: N = 17. M:F 13:4. Mean (SD) age 66 (10). Mean (SD) BMI 28 (4) Preoperative participant characteristics were similar between the two groups. |
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Interventions |
Cell salvage group (Cell salvage/intervention group): in the cell salvage group, a cell saving system was used to collect residual blood within the CPB circuit at the end of the operation. The blood was salvaged using a double‐lumen suction tube flushed with heparinised normal saline. The device used was the Haemonetics Cell Saver 5 (Haemonetics Corporation, Braintree, MA, USA). A 225 mL collection bowl was used. Salvage blood was washed and centrifuged prior to re‐transfusion at the time of skin closure. Cardiotomy suction blood was returned to the venous reservoir without processing. Control group: the control group had no residual CPB blood re‐transfused and all blood lost from skin incision to commencement of CPB and from protamine reversal to skin closure was discarded via a waste sucker. During CPB, blood was collected via cardiotomy suction into the venous reservoir without processing. |
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Outcomes | Outcomes reported: estimated blood loss, intraoperative blood transfusion, number of participants with intraoperative transfusion, postoperative blood transfusion, number of participants with postoperative transfusion, length of stay, atrial fibrillation, cardiovascular events, mortality | |
Notes |
Transfusion protocol: use of a transfusion protocol was not reported. Prospective registration status: the study was not prospectively registered with a trials registry. Ethical approval: the study was approved by the ethics committee of the Policlinico University Hospital of Bari, Italy. Language of publication: English Trial funding: none reported Conflicts of interest: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed using a computer generation randomisation sequence on the day before surgery. |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment |
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 |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | High risk | No mention of blinding. Other outcomes not well‐defined, subject to possible bias |
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 | High risk | No mention of blinding. Other outcomes not well‐defined, subject to possible bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants randomised are accounted for within the outcomes |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | High risk | Conflicts (none) and funding (none) reported. Some baseline imbalance, though authors claim it was not statistically significant, despite it being a large difference that could impact outcomes (gender, and previous cardiovascular event) |