| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Report: "Patients were randomly assigned using a computer-generated randomization sequence, with balanced permuted blocks of two. The sequence was prepared centrally at the Data Center. Both treatment and placebo were concealed
using opaque bags and tape to cover the infusion line."
Protocol: “The randomization of participating subjects will be conducted by the person in charge of randomizing the study using an electronic system. Only the person responsible for randomization and the physician in the Transfusion Medicine Central Team administering treatment will know the product administered to each patient (unblind). Neither the patient nor the researchers will have knowledge of the administered treatment, conducting a double-blind study. The unblind team will keep a record of the product assignments and their administrations that will be kept confidential.” Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “A randomized, double-blind, placebo-controlled study. Neither the patient nor the researchers will have knowledge of the administered treatment”.
Comment: Blinded study (patients and physicians). Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 160 patients randomized; 160 patients analyzed.
Data available for all participants. Risk assessed to be low for the outcomes: Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Blinded study (outcome assessor).
Risk assessed to be low for the outcomes: Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan were available. Data presented appropriately.
Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Adverse events. Serious adverse events |
| Overall risk of bias |
Low |