Bharathan 2016.

Study characteristics
Methods	Randomised, double‐blind, clinical trial Country: India Single centre Period of recruitment: January 2012 to December 2013 Number randomised: 100 (1:1) Postrandomisation dropouts: 1 (1%) from prostaglandin group Lost to follow‐up: not reported Haemodynamic instability Inclusion criteria: adults undergoing liver transplantation Exclusion criteria: ABO‐incompatible liver transplantation, diseased donor liver transplantation, auxiliary partial orthotopic liver transplantation, and people with acute liver failure who were already receiving prostaglandin infusion at time of transplantation
Participants	Experimental: 49 (41 men and 8 women) Control: 50 (47 men and 3 women) Mean age (years): 43 Women: 11 (11.1%) The authors reported per‐protocol analysis. However, when we added the postrandomisation dropout, for the sensitivity analysis, the total number of participants in the experimental group was 50.
Interventions	Experimental: intravenous PGE1 (alprostadil) 0.25 μg/kg/hour, starting 1 hour after portal venous reperfusion, and continued for 96 hours Control: placebo (normal saline)
Outcomes	Primary outcome Early allograft dysfunction Secondary outcomes Peak and mean levels of bilirubin, creatinine, and international normalised ratio over the first 14 postoperative days Peak levels of AST and ALT over first 14 postoperative days Hepatic artery thrombosis, primary non‐function, acute kidney injury, postoperative bleeding, post‐transplant hospital stay, and overall inhospital mortality Follow‐up (months): 1
Notes	Source of funding: not reported Trial name/trial registry number: Clinical Trials Registry of India (Registry No. CTRI/2013/13/09/003991) Contacted Dr Bharathan via email viju505@gmail.com. Unpublished data on number of participants retransplanted and role of individual authors within the study were sought and provided.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation performed using a computer‐generated randomisation sequence.
Allocation concealment (selection bias)	Low risk	Quote: "… sealed opaque envelopes, which were opened on the morning of surgery by the unblinded study coordinator."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "… senior staff nurse who prepared the infusion … delivered to the operating room …' After starting the infusion, the participants were initially monitored by the initiating anaesthetist, and subsequently monitored in the Transplant Intensive Care Unit by the blinded critical care specialist.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All primary end points and most secondary end points were observer‐reported outcomes not involving judgement.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcomes of all randomised participants provided.
Selective reporting (reporting bias)	Low risk	Published protocol available. ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5798&EncHid=&userName=003991
Other bias	Unclear risk	Baseline imbalance present as the number of participants undergoing emergency living donor liver transplantation for acute liver failure was higher in the study arm (7 participants in the experimental arm versus 3 participants in control arm). Trial was stopped when the planned sample size was reached. Per‐protocol analysis performed.