Laine 2018.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm trial Setting: university teaching hospital (Finland) Recruitment: June 2014 to December 2015 Maximum follow‐up: 7 days after hospital |
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Participants | Patients undergoing non‐emergency CABG, simple 1‐valve (aortico mitral) replacement, or both, requiring cardiopulmonary bypass (CPB)
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Interventions |
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Outcomes | ROTEM was performed at 3 predetermined time points: before anaesthesia induction, immediately after CPB/surgery, and on the first postoperative morning | |
Notes |
Trial registration: after trial was registered at the Hospital District of Helsinki and Uusimaa (§94,9.05.2014) [sic] and receiving approval from the institutional Ethics Committee for Surgery in Helsinki University Hospital 2014 (D‐number 58/13/03/02/2014) Trial funding: this work was supported by a government grant for medical research and by the Finnish Angiological Society COI statement by investigators: "Dr. Laine has received congress related travel reimbursement from MSD Finland Oy. Dr. Schramko has received congress related travel reimbursement from TEM InternationalGmBH" (Laine 2018 p 132) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomization was done in blocks of 20" (Laine 2018 p 133) ‐ no further information given |
Allocation concealment (selection bias) | High risk | "... using closed envelopes" ‐ no further information given (Laine 2018 p 133) |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Blinding of personnel for this intervention is not feasible, but in our view, for objective outcomes such as mortality (the primary outcome used within this review), we graded risk of bias as 'low' Clinical staff blinded to ROTEM results |
Blinding of outcome assessment (detection bias) Objective measures | Low risk | Blinding of mortality (the primary outcome used within this review) is not relevant, and we graded risk of bias as 'low'. Laboratory outcomes including ROTEM results are also considered hard outcomes |
Blinding of outcome assessment (detection bias) Subjective measures | Low risk | No data from subjective outcomes (e.g. function) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "All 80 patients were included in the analyses" (Laine 2018 p 134) |
Selective reporting (reporting bias) | Unclear risk | Evidence of prospective registration/trial protocol unavailable; insufficient information to make a judgement |
Other bias | Low risk | None evident |