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) |