Bergamin 2017.
| Study characteristics | ||
| Methods |
Design: RCT, parallel 2‐arm, single‐site trial Setting: ICU, tertiary (university teaching hospital), São Paulo, Brazil Recruitment: June 2012 to May 2014 Maximum follow‐up: 90 days |
|
| Participants | 300 participants 18 years of age or older with a diagnosis of solid cancer and septic shock in ICU
|
|
| Interventions | Liberal transfusion at Hb < 9 g/dL Restrictive transfusion at Hb < 7 g/dL |
|
| Outcomes |
Primary outcome: 28‐day mortality Secondary outcomes: need for advanced organ support (invasive mechanical ventilation, inotropic therapy, or renal replacement therapy), cerebral ischaemia (diagnosed by imaging and new focal deficit), acute myocardial infarction, mesenteric ischaemia, limb ischaemia, and serious adverse reactions (haemolytic transfusion reactions, anaphylaxis, transfusion‐associated lung injury, or transfusion‐associated circulatory overload) in the 28 days after randomisation; ICU and hospital length of stay; ICU re‐admission; death by 60 and 90 days after randomisation |
|
| Notes |
Trial title: Transfusion Requirements in Critically Ill Oncologic Patients (TRICOP) Trial registration: NCT01648946. Study start date was June 2012. Registration first submitted 19 July 2012; posted 25 July 2012 Trial funding: not reported. Sponsor was Instituto do Cancer do Estado de São Paulo, Brasil COI statement by investigators: "Dr. Park disclosed government work. The remaining authors have disclosed that they do not have any potential conflicts of interest" (Bergamin 2017 p 766) |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Eligible patients were randomly assigned to the liberal or restrictive RBC transfusion strategy by means of an Internet based system that concealed assignments" (Bergamin 2017 p 767) |
| Allocation concealment (selection bias) | Low risk | As above |
| 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' |
| Blinding of outcome assessment (detection bias) Objective measures | Low risk | "Two blinded investigators assessed primary and secondary outcomes by patient records review or by telephone call (long‐term survival). There was no identification of transfusion strategy group on patients, patient records, or patient beds. Patients and investigators who collected outcomes had no access to transfusion data and were unaware of the group assignment" (Bergamin 2017 p 767) "Transfusion decisions were not performed blindly ... Physicians and nurses of the ICU were aware of the groups of treatment ... Patients were unaware of the group assignment" (Bergamin 2017 p 767) |
| 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 | No loss to follow‐up; data analysed on intention‐to‐treat model |
| Selective reporting (reporting bias) | Low risk | Outcomes as specified in the trial registration (NCT01648946) appear in full in the published paper |
| Other bias | Low risk | None identified |