Mac 1993.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: private, non‐profit tertiary care hospital Recruitment: August 1990 to February 1991 Maximum follow‐up: 1 year postoperatively |
|
Participants |
Group 1 (Constavac) (Cell salvage/intervention): N = 56. Mean age 66.4. M:F (%) 50:50 Group 2 (Haemovac) (Control/no cell salvage): N = 35. Mean age 63.9. M:F (%) 37:63 There was baseline imbalance in ASA score between the groups. |
|
Interventions |
Group 1 (Constavac) (Cell salvage/intervention): postoperative autoreinfusion device Group 2 (Haemovac) (Control/no cell salvage): standard drain used postoperatively |
|
Outcomes | Outcomes reported: blood loss, blood replacement, length of hospital stay | |
Notes |
Transfusion protocol: on the day of surgery, blood was transfused at the discretion of the surgeon. On postoperative days 1 and 2, blood was transfused for a haemoglobin below "10 vols/100 mL". Prospective registration status: the study was published prior to 2010. Ethical approval: it is not clear whether the study was approved by an ethics committee or institutional review board. 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) | High risk | Original randomisation methods unclear. Randomisation was broken as 15 participants were reassigned after randomisation to ConstaVac group by operating surgeon |
Allocation concealment (selection bias) | Unclear risk | Operating staff not aware of allocation until procedure but explicit method of concealment not reported e.g. sealed opaque envelopes |
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 | Decisions on blood transfusion varied depending on the day. Quote: "On the day of surgery, blood was transfused at the discretion of the surgeon. On postoperative days 1 and 2, blood was transfused for a haemoglobin below 10 vols/100ml." |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Low risk | Intraoperative allocation only shared at end of operation. Postoperative transfusion threshold in place and standard care described as consistent. Physician blinded for most of the procedure until drain inserted. |
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 | Undefined protocol for LOS and blood loss measurement, once blinding was broken |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Poorly described |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | High risk | No conflict of interest or funding declaration. Baseline imbalance of groups (ASA grade) and uneven group size |