Schnurr 2018.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, multicentre study Setting: 3 hospitals in Germany (1 university teaching hospital, 2 general hospitals) Recruitment: April 2015 to June 2016 Maximum follow‐up: 42 days postoperatively |
|
Participants | 200 participants undergoing total knee arthroplasty were randomised to one of two groups: Autologous blood transfusion drain (Cell salvage/intervention group): N = 100. M:F 24:76. Mean age 70. Mean BMI 31. Redon drain group (Control/no cell salvage group): N = 100. M:F 31:69. Mean age 70. Mean BMI 30. Demographic and preoperative variables were comparable between the two groups at baseline assessment. |
|
Interventions |
Autologous blood transfusion drain (Cell salvage/intervention group): the ABT group received an OrthoPAT (Haemonetics, Braintree, USA) re‐transfusion drain, connected to the intra‐articular drain for 6 hours postoperatively. At 6 hours, the transfusion system was replaced with a Redon drain without vacuum assistance. Redon drain group (Control/no cell salvage group): the Redon group received a Redon drain without vacuum assistance connected to the intra‐articular drain. Drains in both groups were removed after 24 hours. |
|
Outcomes | Outcomes reported: blood loss, number of participants exposed to allogeneic blood transfusion, volume of allogeneic blood transfused, complications | |
Notes |
Transfusion protocol: autologous transfusion was initiated for the following reasons:
The following transfusion triggers were used for allogeneic blood transfusions in both groups:
When a transfusion was required, a single unit of blood (300 mL) was given and re‐evaluation was performed 6 hours afterwards. Prospective registration status: the study was not prospectively registered with a trials registry Ethical approval: the study was approved by the Institutional Review Board for Ärztekammer Nordrhein, Düsseldorf, Germany (reference number 2014378) Language of publication: English Trial funding: none reported Conflicts of interest: none reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised to one of two groups using 200 pre‐prepared sealed (shuffled) envelopes containing the group name. One of the sealed envelopes was selected by the anaesthetist |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes were pre‐prepared prior to randomisation process, no mention of opaqueness |
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: (A) Participants with no history of a coronary heart disease: 1. haemoglobin < 10 g/dL and symptoms of anaemia (nausea, vomiting, hypotension, tachycardia, cardiac symptoms); 2. haemoglobin < 7 g/dL with or without symptoms of anaemia. (B) Participants with a history of a coronary heart disease: 1. haemoglobin < 10 g/dL and symptoms of anaemia (nausea, vomiting, hypotension, tachycardia, cardiac symptoms); 2. haemoglobin < 9 g/dL with or without symptoms of anaemia. Where a transfusion was required, a single blood unit (300 mL) was given. |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Unclear risk | No information is available regarding the blinding of outcome assessors |
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 | No information is available regarding the blinding of outcome assessors, but transfusion protocol and blood loss calculation thorough. Not sure how PJI and wound complications were determined |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No mention of individuals identified who did not meet criteria or loss to follow‐up |
Selective reporting (reporting bias) | High risk | No trial registration or published protocol is available to compare, but there is discrepancy between the described outcome measures in the methodology and those presented in the results. |
Other bias | Low risk | No baseline imbalance, conflicts declared (none), funding declared (none) |