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

Pavelescu 2014.

Study characteristics
Methods Design: RCT, parallel three‐arm, single‐centre study
Setting: regional hospital, Bucharest, Romania
Recruitment: 1 year study. Recruitment and study dates not reported
Maximum follow‐up: 24 hours postoperatively
Participants 78 participants undergoing total knee arthroplasty were randomised to one of three groups:
Group A (No tranexamic acid and standard vacuum drainage group)
Group B,C (Tranexamic acid group, no drain) (Control/no cell salvage group)
Group C (Tranexamic acid and reinfusion system) (Cell salvage/intervention group)
Age range for the study was 51 to 89 years.
Interventions Group A (No tranexamic and standard vacuum drainage group): received a standard vacuum drain and no tranexamic acid
Group B,C (Tranexamic acid group, no drain) (Control/no cell salvage group): received tranexamic acid, 10 mg/kg administered intravenously prior to tourniquet release
Group C (Tranexamic acid and reinfusion system) (Cell salvage/intervention group): received tranexamic acid 10 mg/kg intravenously prior to tourniquet release and had a reinfusion system drainage sited at the end of surgery
Outcomes Outcomes reported: mean allogeneic blood transfusion volume, number of participants requiring allogeneic blood transfusion, rate of thromboembolic events
Notes Transfusion protocol: blood transfusion was made at Hb < 9 g/dL or with symptomatic anaemia
Prospective registration status: information on whether the trial was registered prospectively is not available. No contact information is available for the authors to clarify this.
Ethical approval: it is unclear whether ethical approval was granted for the study. No contact information is available for the authors to clarify this.
Language of publication: the abstract was written in English
Study groups: for the purpose of our review, we have used Group C as our cell salvage/intervention group and Group B/C as our control group. By using Group B,C as a control group, we hope to neutralise any effect of tranexamic acid.
Trial funding: not reported
Conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Abstract only
Allocation concealment (selection bias) Unclear risk Abstract only
Blinding of participants and personnel (performance bias)
Objective outcome: mortality Low risk Abstract only. 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 Unclear risk Transfusion protocol in place: blood transfusion was made at Hb < 9 g/dL or with symptomatic anaemia. Significant scope for between‐participant variability. More information may be available in a full publication (abstract only)
Blinding of participants and personnel (performance bias)
Subjective: all other outcomes Unclear risk Abstract only
Blinding of outcome assessment (detection bias)
Objective outcomes: mortality and transfusions Low risk Abstract only. 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 Abstract only
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Abstract only
Selective reporting (reporting bias) Unclear risk No trial registration or published protocol, or full text, is available to compare
Other bias Unclear risk Abstract only, with no full‐text publication available. Therefore, there is limited information available upon which to judge the methodological quality of the study.