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. |