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. 2023 Jun 6;2023(6):CD013532. doi: 10.1002/14651858.CD013532.pub2

Prajapati 2017.

Study characteristics
Methods Open‐label randomised controlled trial, single centre
Participants Country: India
Period of recruitment: June 2014 and February 2016
Number randomised: 259
Postrandomisation dropouts: 6
Revised sample size: 253
Average age (years): 54
Males: 83%
Decompensated cirrhosis: 100%
Acute‐on‐chronic liver failure 0%
Alcohol‐related cirrhosis 25%
Viral‐related cirrhosis: 13%
Autoimmune disease‐related cirrhosis: 0%
Other causes of cirrhosis: 50%
Inclusion criteria
  • Inpatients with decompensated cirrhosis. Written informed consent for participation in the study was obtained

  • Aged 18 to 75 years

  • Patients with decompensated cirrhosis with Child–Turcotte–Pugh of at least 6 and 13 or less. Decompensation was defined as the occurrence of any of the following events: ascites, encephalopathy, variceal bleeding, jaundice, or hepatorenal syndrome.

  • Patients who were listed for transplantation, but for whom liver transplantation was not feasible soon because of financial reasons or unavailability of donors (in India, most transplants are living donor liver transplantations that are self‐funded)


Exclusion criteria
  • Hepatocellular carcinoma or any other malignancy

  • Sepsis (patients were included after sepsis was controlled)

  • Severe cardio or pulmonary disease

  • Grade 3 or 4 hepatic encephalopathy, active variceal bleeding, and HRS. Patients were included after clinical improvements in these conditions.

  • HIV seropositivity

  • Pregnancy

  • Refusal to participate in the study

  • Previous known hypersensitivity to G‐CSF

Interventions Experimental
  • G‐CSF for 5 days at a dose of 5 μg/kg subcutaneously twice a day, and standard medical therapy


Control
  • Standard medical therapy alone


All participants received standard medical therapy.
Standard medical therapy included antivirals, abstinence from alcohol, nutrition, diuretics, β‐blockers, selective intestinal decontamination, and other supportive measures depending on clinical status and requirement.
Outcomes Primary outcome
  • Improvement in survival at 6 months


Secondary outcome
  • Improvement in clinical outcome according to the CTP score

Notes Conflicts of interest: "There are no conflicts of interest."
Funding: no information
ClinicalTrials.gov number: NCT02642003
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The randomisation sequence remained with the statistician.
Allocation concealment (selection bias) Low risk The sequence remained concealed from the investigators until the intervention was assigned.
Blinding of participants and personnel (performance bias)
All outcomes High risk This was an open‐label study.
Blinding of outcome assessment (detection bias)
overall mortality Low risk No information was given, but for the mortality outcome, low risk of bias.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No information was given.
Incomplete outcome data (attrition bias)
All outcomes High risk Twenty participants were lost at follow up (treatment arm: 9, control arm: 11).
Selective reporting (reporting bias) Low risk The trial reported all‐cause mortality as a primary outcome.
Other bias Low risk We found no other bias.