title: Effectiveness of prothrombin complex concentrate (PCC) in neonates and infants with bleeding or risk of bleeding: a systematic review and meta-analysis.
abstract: To systematically evaluate the effectiveness of prothrombin complex concentrate (PCC) in neonates and infants, we performed a systematic review and meta-analysis based on current evidence. Quality of studies was assessed by Cochrane Collaboration's risk of bias tool and Newcastle-Ottawa quality assessment scale. For dichotomous data, we obtained the number of events and total number and calculated the relative risk (RR) with 95% confidence intervals (CI). For continuous variables, we obtained mean and standard deviation (SD) values and calculated mean difference (MD) with 95% CI. We identified six trials and two cohort studies. For trials, selection bias and performance bias were high, while detection bias, attrition bias, and reporting bias were relatively low. For cohort studies, selection bias was low. Both individual studies and meta-analysis failed to find any benefit of PCC on mortality. Meta-analysis also failed to show any benefit in reducing intracranial hemorrhage. The effectiveness of PCC on the correction of hemostatic defects was inconsistent among studies. In addition, PCC was not more effective than fresh frozen plasma (FFP) in correcting hemostatic defects.
  
  
  CONCLUSIONS
  There is insufficient evidence to allow a recommendation for use of PCC in neonates and infants. What is Known: • Prothrombin Complex Concentrate is becoming increasingly used off-label for treatment of neonates and infants with severe bleeding or risk of severe bleeding. • Some case reports showed PCC seemed to be effective for infants and children with coagulation factor deficiency, but evidence about the effectiveness of PCC to reverse serious Vitamin K Deficiency Bleeding is limited. What is New: • As far as we know, this is the first systematic review that evaluates the effectiveness of PPC in neonates with bleeding or risk of bleeding. • There is insufficient evidence to allow a recommendation for use of PCCs in neonates and infants.
authors.affiliation: Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China.|Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China.
authors.forename: Linan
authors.initials: L
authors.lastname: Zeng
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Imti
authors.initials: I
authors.lastname: Choonara
authors.affiliation: Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China. zhanglingli@scu.edu.cn.|Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China. zhanglingli@scu.edu.cn.
authors.forename: Lingli
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Chinese Evidence-Based Medicine Centre/Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu, China. yzmylab@hotmail.com.
authors.forename: Youping
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Neonatology, West China Second University Hospital, Sichuan University, Chengdu, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Shi
mesh_terms: D001778:Blood Coagulation Disorders / Q000150:complications; D001779:Blood Coagulation Factors / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D056687:Off-Label Use; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D014813:Vitamin K Deficiency / Q000150:complications
chemical_list: D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates
keywords: Infants; Meta-analysis; Neonates; Prothrombin complex concentrate; Systematic review