Ekback 1995.
Study characteristics | ||
Methods |
Design: RCT, parallel three‐arm, single‐centre study Setting: university teaching hospital, Örebro, Sweden Recruitment: recruitment and study dates not reported Maximum follow‐up: 7 days postoperatively |
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Participants | 45 participants undergoing total hip arthroplasty were randomly allocated to one of three groups: Group 1 (Control/no cell salvage group): n = 15 Group 2 (Cell salvage/intervention group): n = 15 Group 3 (Autologous pre‐donation plus cell salvage group): n = 15 Demographic data were not reported; however, the authors state that there were no differences between groups with regard to demographic data. Participants in Groups 2 and 3 had significantly higher blood volume than those in Group 1. |
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Interventions |
Group 1 (Control group/no cell salvage): blood loss was replaced with heterologous erythrocyte concentrate (SAGM‐ERC) and 3% dextran 60 in a ratio of 1:1. If necessary, additional SAGM‐ERC was transfused to correct erythrocyte volume fraction (EVF) > 27%. Group 2 (Cell salvage/intervention group): blood loss was replaced with 3% dextran and by autotransfusion of washed and haemoconcentrated blood salvaged by intraoperative suction and from wound drains up to 4 hours postoperatively. Haemonetic Cell Saver 4, Althin model AT 1000, or Shiley/Dideco STAT were used. Blood was retrieved from the operation site by suction through a double lumen catheter and was then anticoagulated with heparin (30,000 IU heparin in 1000 mL of physiological saline). The blood was collected into a reservoir where a macrofilter removed debris. Thereafter, the blood was pumped into a spinning centrifuge bowl (125 mL of blood) and washed with 1500 mL of physiological saline. The erythrocytes were concentrated to an EVF of about 50% to 60% and pumped into an infusion bag. The effluent containing platelets, free haemoglobin, and anticoagulants was disposed. As in Group 1, additional SAGM‐ERC was transfused to correct erythrocyte volume fraction (EVF) > 27%. Group 3 (Autologous pre‐donation plus cell saver group): blood loss was replaced with 3% dextran and by autotransfusion of washed and haemoconcentrated blood salvaged by intraoperative suction and from wound drains up to 4 hours postoperatively, as per the technique described for Group 2. Pre‐donated autologous SAGM‐ERC was used instead of heterologous blood to maintain erythrocyte volume fraction (EVF) > 27%. In 2 to 3 sessions within 6 weeks prior to the operation, 2 to 3 units of SAGM‐ERC had been withdrawn. If necessary, heterologous SAGM‐ERC was used if transfusion of all pre‐donated autologous blood failed to maintain EVF > 27%. |
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Outcomes | Outcomes reported: amount of allogeneic blood transfused, amount of autologous blood transfused, number of participants transfused allogeneic blood, complications, adverse events | |
Notes |
Transfusion protocol: participants were transfused allogeneic blood to maintain the erythrocyte volume fraction (EVF) > 27%. Prospective registration status: the study was published prior to 2010. Ethical approval: the study was approved by the local hospital ethics committee. Language of publication: English Study groups: for the purposes of our review, Group 2 was used as the cell salvage/intervention group, while Group 1 was used as the control/no cell salvage group. 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 | Method used to conceal treatment allocation was unclear |
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: "additional heterologous SAGM‐ERC was transfused to maintain EVF > 27%" |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | High risk | No info on blinding ‐ may impact clinical decision‐making related to blood loss |
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 | High risk | No info on blinding ‐ may impact clinical decision‐making related to blood loss |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No info on participant flow; 15 per group (45 total) at baseline, but unclear whether all were analysed |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | High risk | Funding and conflicts not reported. Some baseline imbalance: "Due to the small group sizes in our study, well balanced groups could not be achieved; a lower preoperative calculated blood volume in group I (Table 1); a higher preoperative APTT (within normal values) in group 2 ( Table 2); a lower preoperative R 1 (within normal values) in group 2 (Fig. (3 patients had Rl < 15%/min) were found." |