Prothrombin complex concentrate for reversal of vitamin K antagonist treatment in bleeding and non‐bleeding patients

摘要: Background Treatment with vitamin K antagonists is associated increased morbidity and mortality. Reversal therapy prothrombin complex concentrate (PCC) used increasingly recommended in the treatment of patients bleeding complications undertaking surgical interventions, as well at high risk bleeding. Evidence lacking regarding indication, dosing, efficacy safety. Objectives We assessed benefits harms PCC compared fresh frozen plasma acute medical setting involving antagonist-treated non-bleeding patients. We investigated various outcomes predefined subgroups performed sensitivity analysis. examined risks bias applied trial sequential analyses (TSA) to examine level evidence, we prepared a 'Risk bias’ table test quality evidence. Search methods We searched following databases from inception 1 May 2013: Cochrane Central Register Controlled Trials (CENTRAL); MEDLINE (Ovid SP); EMBASE International Web Science; Latin American Caribbean Health Sciences Literature (LILACS) (via BIREME); Chinese Biomedical Database; advanced Google Cumulative Index Nursing Allied (CINAHL). systematic sensitive search strategy identify relevant randomized clinical trials imposed no language or date restrictions. adapted our for searches all other databases. reran October 2014 found one potential new study interest. added this list ‘Studies awaiting classification', will incorporate into formal review findings time update. Selection criteria We included controlled (RCTs), irrespective publication status, publication, blinding published language. contacted investigators authors request data. Data collection analysis Three independently abstracted data resolved disagreements by discussion. Our primary outcome measures were 'overall mortality longest follow-up' 28-day mortality'. subgroup assess effects adults terms physiological outcomes. presented pooled estimates interventions on dichotomous ratios (RRs), continuous mean differences (MDs), 95% confidence intervals (CIs). assessing methodological components random error through TSA. Main results We four RCTs total 453 participants determined that none these had overall low bias. six ongoing which unable retrieve further data. Three provided Meta-analysis showed statistical effect (RR 0.93, CI 0.37 2.33; very evidence). associate use number probably related intervention 0.92, 0.78 1.09; Lack transfusion apparent design prevented finding beneficial reducing volume (FFP) transfused reverse antagonist treatment. The occurrences red blood cells (RBCs) did not seem be 1.08, 0.82 1.43; Still, studies demonstrate possibility equally reversing K-induced coagulopathy using without need FFP. No was observed. Authors' conclusions In RCTs, does appear reduce requirements but demonstrates plasma. All have are underpowered detect mortality, benefit harm. Clinical heterogeneity high, definitions clinically important such adverse events highly dissimilar between trials. Only weak observational evidence currently supports patients, current support routine over Additional high-quality research urgently needed.