Shenolikar 1997.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: regional hospital, Swansea, Wales, UK Recruitment: recruitment and study dates not reported Maximum follow‐up: 3 months postoperatively |
|
Participants | 100 consecutive participants undergoing total knee replacement were randomised to one of two groups: Autologous group (Cell salvage/intervention group): N = 50. M:F 21:29. Mean (range) age males 70.4 (47 to 78 years). Mean (range) age females 69.3 (52 to 81) Allogeneic group (Control/no cell salvage): N = 50. M:F 24:26. Mean (range) age males 67.9 (51 to 82). Mean (range) age females 70.8 (46 to 88) Demographic variables were similar between the two groups at baseline; however, no formal statistical comparison was performed. |
|
Interventions |
Autologous group (Cell salvage/intervention group): cell salvage group participants had postoperative drainage blood processed by a Haemonetics Cell Saver 3. Blood was collected via the wound drains following the release of the tourniquet. The collected blood was anticoagulated with heparinised saline. The machine aspirated the wound drainage into the centrifuge bowl via roller pumps. The blood underwent accelerated sedimentation, being spun at 5600 revs/minute. The supernatant was discarded and the resulting red cells washed and re‐suspended in normal saline. The machines produced a product with a haematocrit of over 55% and a volume of 250 mL. Allogeneic group (Control/no cell salvage): control group did not receive autotransfusion. |
|
Outcomes | Outcomes reported: amount of blood collected by the cell saver, amount of allogeneic blood transfused, number of participants transfused allogeneic blood, adverse events, hospital length of stay | |
Notes |
Transfusion protocol: allogeneic blood was given in the postoperative period when the haemoglobin fell below 9.0 g/dL. Routine procedure of crossmatching two units of packed cells was performed for all participants in the study. Prospective registration status: the study was published prior to 2010. Ethical approval: the study was approved by the local research ethics committee. Language of publication: English Trial funding: not reported Conflicts of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Method used to generate allocation sequences was adequate. A computer‐generated randomisation schedule was used |
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 in place: when the postoperative haemoglobin of participants in the autologous group fell below the preset haemoglobin trigger (9 g/dL), they were rescued with an allogeneic blood transfusion |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Unclear risk | The blinding status of participants and personnel was not described. No detail on how decisions were made for remaining outcomes |
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 | Unclear risk | The blinding status of participants and personnel was not described. No detail on how decisions were made for remaining outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants randomised are accounted for in the reported outcomes. 100 randomised, 100 analysed |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Unclear risk | No baseline imbalance. No mention of funding or conflicts |