Pfizer 2011.

Methods	Prospective open label phase 4 randomised controlled trial
Participants	Population: 81 patients between 18 and 50 years of age who underwent surgery for fracture shaft femur Setting: India Date the study was conducted: 2009‐2010
Interventions	Intervention: tranexamic acid slow IV 15mg/kg 15 mins before surgery, followed by 2nd dose 3 hrs later and a 3rd dose 3 hrs later Control: standard care
Outcomes	Primary outcome: blood loss; secondary outcome: deep venous thrombosis. Pulmonary embolism, transfusion and deaths were also reported.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of outcome assessment (detection bias) Mortality	Low risk	Quote: Open label Review authors' judgement: low risk of bias for mortality
Blinding of outcome assessment (detection bias) Transfusion	Unclear risk	Quote: Open label
Blinding of outcome assessment (detection bias) Complications	Unclear risk	Quote: Open label
Incomplete outcome data (attrition bias) Mortality	Low risk	Quote: Intention to treat analysis and 17% loss to follow‐up
Incomplete outcome data (attrition bias) Transfusion	Low risk	Quote: Intention to treat analysis and 17% loss to follow‐up
Incomplete outcome data (attrition bias) Complication	Low risk	Quote: Intention to treat analysis and 17% loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	No protocol available
Other bias	Unclear risk	‐