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. 2023 Sep 8;2023(9):CD001888. doi: 10.1002/14651858.CD001888.pub5

Spark 1997.

Study characteristics
Methods Design: RCT, parallel two‐arm, single‐centre study
Setting: university teaching hospital, Leeds, Yorkshire, UK
Recruitment: recruitment and study dates not reported
Maximum follow‐up: duration of hospital stay
Participants 50 participants undergoing elective infrarenal abdominal aortic aneurysm surgery were randomised to one of two groups:
Autologous blood (Cell salvage/intervention group): N = 23. M:F 19:4. Median (IQR) age 71 (54 to 78)
Homologous blood (Control/no cell salvage group): N = 27. M:F 20:7. Median (IQR) age 68 (54 to 82)
There was no imbalance between groups at baseline.
Interventions Autologous blood (Cell salvage/intervention group): cell salvage group participants received autologous blood via intraoperative autotransfusion (IAT). A COBE Baylor rapid autologous transfusion system was employed for intraoperative cell salvage. Blood was retrieved from the operative site by suctioning into a double lumen catheter at < 150 mmHg, to minimise haemolysis. Blood was anticoagulated with heparin (30,000 units/1 litre 0.9% saline). The salvaged blood was then collected in a reservoir where a macrofilter of 150 µm removed larger particles of debris. When 500 mL of blood was collected, it was pumped to a spinning centrifuge bowl. The red cells were washed with 0.9% saline, and concentrated to an Hct above 50%. The effluent containing plasma fractions, platelets, leukocytes, free haemoglobin, anticoagulant, and saline was discarded. The washed red cells, suspended in saline, were pumped from the centrifuge to the patient through a microfilter of either 20 µm or 40 µm.
Homologous blood (Control/no cell salvage group): control group did not receive autotransfusion.
Outcomes Outcomes reported: amount of allogeneic blood transfused, number of participants transfused allogeneic blood, adverse events, hospital length of stay, blood loss, mortality
Notes Transfusion protocol: participants were transfused allogeneic blood if the Hct fell below 25%.
Prospective registration status: the study was published prior to 2010.
Ethical approval: the study protocol was approved by the local ethics committee.
Language of publication: English
Trial funding: Yorkshire Vascular and Surgical Research Fund
Conflicts of interest: not reported
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 Using sealed envelopes (does not state whether they were opaque)
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 High risk No transfusion protocol in place
Blinding of participants and personnel (performance bias)
Subjective: all other outcomes High risk No mention of blinding; multiple outcomes lack guidelines/diagnostic criteria needed to avoid bias
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 mention of blinding; multiple outcomes lack guidelines/diagnostic criteria needed to avoid bias
Incomplete outcome data (attrition bias)
All outcomes Low risk ITT analysis
Selective reporting (reporting bias) Unclear risk No trial registration or published protocol is available to compare
Other bias Low risk No baseline imbalance. Funding reported (non‐pharmaceutical)