Avvisati 1989.

Methods	Parallel RCT. 2 centres (Italy and The Netherlands). Enrolment period not stated.
Participants	Inclusion criteria: people with newly diagnosed APML who met the following criteria: age 15 to 60 yrs; ventricular ejection fraction > 50%; serum alanine aminotransferase (ALT) < 4 x upper limit of normal; creatinine < 177 μmol/L. Exclusion criteria: not stated Arm 1 N = 6 (APML N = 6) Arm 2 N = 6 (APML N = 6) Age range 17 to 59 years
Interventions	Comparison between TXA and placebo Arm 1 TXA (2 g given as a continuous infusion every 8 hours for the first 6 days of antileukaemic treatment) Arm 2 Placebo (equal volume of 5% glucose) RBC transfusion thresholds: packed red cells given to maintain Hb > 90 g/L Platelet transfusion threshold: 6 to 8 U/m2 (source not stated) routinely given during first 7 days and additionally for overt haemorrhage Packed red cells and additional platelet concentrates given at the discretion of the attending physician
Outcomes	Main or primary outcome not stated Outcomes reported: Severity of bleeding Thromboembolism Laboratory assessment of fibrinolysis Packed red cell transfusion requirement Platelet concentrate transfusion requirement Number of days participants from both arms on study: 14
Notes	Patients randomised at: not reported Follow‐up of participants: for 14 days from start of antileukaemic treatment Stopping guidelines: not reported Funding: "This work was supported by grants from the Amstol Foundation (A 584), Amsterdam, the Netherlands and the Italian National Research Council (86.00466.44); and by a Royal Dutch Academy of Sciences Fellowship (H. R. B.)." Declarations of interest: Not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Participants were randomised to either TXA or placebo. The article does not state how participants were randomised.
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	The article states that "Patients and attending physicians were blinded to the treatment groups" and that bleeding assessments were examined by the same investigator but it is not clear whether the investigator was one of the attending physicians.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Each patient was examined daily by the same investigator (G.A.) for clinically manifest haemorrhage during the entire study of 14 days". Unclear whether G.A. was blinded to the treatment groups
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing outcome data
Selective reporting (reporting bias)	Unclear risk	The article states that their efficacy endpoints were "severity of bleeding" and the packed red cell and platelet concentrate transfusion requirement but also reports outcome data for laboratory assessment of coagulation and fibrinolysis. It also states that there were no episodes of thromboembolism. We would be concerned as to what other outcomes were measured and not reported.
Other bias	Low risk	The study seemed to be free of other sources of bias
Protocol deviation balanced?	Unclear risk	Protocol deviations or violations were not commented on