Goel 2007.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: specialist cardiothoracic surgery hospital, Amritsar, Punjab, India Recruitment: March 2004 to June 2004 Maximum follow‐up: 5 days postoperatively |
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Participants | 50 participants undergoing 'off‐pump' first‐time CABG were randomised to one of two groups: Group C (Cell saver/intervention group): N = 24. M:F 21:3. Mean (SD) age 58.2 (8.7) Group N (Control/no cell saver group): N = 25. M:F 21:4. Mean (SD) age 61.9 (10.0) There were no between‐group differences at baseline. NB: one participant in the autotransfusion group (intervention group) was excluded from the final analysis due to conversion to cardiopulmonary bypass ('on‐pump'). |
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Interventions |
Group C (Cell saver/intervention group): the cell salvage group (Dideco autotransfusion system) had all intraoperative shed blood collected from the time of incision until skin closure. Blood was aspirated using a single lumen, high‐pressure suction cannula flushed with heparinised saline and collected in the reservoir of the cell saver device. The collected blood was then subjected to washing and centrifugation. The processed red blood cells were collected in sterile blood bags and were made available to the anaesthetic staff for autotransfusion. Group N (Control/no cell saver group): the control group had their intraoperative shed blood discarded. |
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Outcomes | Outcomes reported: amount of allogeneic blood transfused, volume of blood re‐transfused from the cell saver, blood loss, adverse events | |
Notes |
Transfusion protocol: the indication for allogeneic blood transfusion in the intraoperative period was a haemoglobin level < 9.0 g/dL or a haematocrit level < 27%. In the autotransfusion group, all the processed red blood cells collected during surgery were re‐transfused as required. Banked allogeneic blood was used only if the haemoglobin level remained < 9.0 g/dL despite autotransfusion. Prospective registration status: the study was published prior to 2010. Ethical approval: the study was approved by the hospital ethics committee. 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 | Method used to generate allocation sequences was not described. |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes were used to conceal treatment allocation. It is not known whether they were opaque. |
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 | Low risk | Transfusion protocol in place: "The threshold for blood transfusion in both the groups was haemoglobin < 9 g d either during the procedure or at any time in the postoperative period" |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Unclear risk | The blinding status of participants and personnel was not well described. |
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 | The blinding status of participants and personnel was not well described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant was excluded for clinical reasons: "Of the 50 participants, 49 completed the study." |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Unclear risk | No baseline imbalance noted. Funding and conflicts not reported |