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. 2017 Apr 21;2017(4):CD011384. doi: 10.1002/14651858.CD011384.pub2

Valderrama 1992.

Methods Randomised clinical trial
Participants Country: Spain
 Number randomised: 105
 Postrandomisation dropouts: 5 (4.8%)
 Revised sample size: 100
 Average age: 57 years
 Women: 53 (53%)
 Acute interstitial oedematous pancreatitis: not stated
 Necrotising pancreatitis: not stated
 Mild pancreatitis: not stated
 Moderate pancreatitis: not stated
 Severe pancreatitis: not stated
 Persistent organ failure: not stated
 Infected pancreatitis: not stated
 Inclusion criteria: people with acute pancreatitis
Interventions Group 1: gabexate mesilate (n = 51), 12 mg/kg/day continuous IV for 4‐12 days based on disappearance of abdominal pain or requirement for surgery
 Group 2: placebo (n = 49)
Outcomes Mortality, serious adverse events, adverse events, sepsis
Follow‐up: not stated (probably until discharge)
Notes Reasons for postrandomisation dropouts: protocol violations
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer generated"
Allocation concealment (selection bias) Low risk Quote: "consecutively numbered boxes containing FOY or placebo"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "double blind"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "double blind"
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: there were postrandomisation dropouts.
Selective reporting (reporting bias) Low risk Comment: mortality and adverse events were reported.
For profit‐bias High risk Quote: "[t]he authors thank Laboratorio Dr Esteve SA for supplies of gabexate mesylate (FOY)".
Other bias Low risk Comment: no other risk of bias