Factors associated with mechanical ventilation longer than 24 h after liver transplantation in patients at risk for bleeding.

"Declarations Ethics approval and consent to participateThe protocol was approved by the institutional review board (IRB) of the lead hospital (University Hospital of Bellvitge, approval number AC 033/18) as well as the IRBs of the other participating centres (University Hospital of Cruces and Clinic Hospital of Barcelona). Patients were enrolled if they gave their written informed consent. Consent for publicationsThe manuscript does not contain any individual data. Competing interestsThe authors declare no competing interests. Competing interests The authors declare no competing interests."

"Funding This study was funded by the Instituto de Salud Carlos III through the project PI17/00743. CSL Behring provided the fibrinogen concentrate. The funders had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. Data quality monitoring was funded by the Spanish Clinical Research Network-UICEC (SCReN) of the Bellvitge Biomedical Research Institute (IDIBELL), Platform SCReN PT17/0017/0010, PT20/000008, State Plan 2020–2017 and EECTI 2021–2027)."

"We acknowledge Mary Ellen Kerans for advising on edits for some versions of the manuscript. The trial was registered in the European Clinical Trials Database (EudraCT 2018-002510-13,) and on ClinicalTrials.gov (NCT01539057). We also acknowledge the help of Mireia Sanllorente and Pilar Hereu, who were project managers for the study; funding for their work was covered by the SCReN Platform. We also thank the CERCA Programme of the Autonomous Government of Catalonia (Generalitat de Catalunya) for institutional support. Data from a multicentre, haemoglobin-stratified, randomised controlled trial on fibrinogen infusion and blood product requirements by our group [] were used for this secondary analysis, which was foreseen in the initial protocol registered in the European Clinical Trials Database (EudraCT 2018–002510-13,) and on ClinicalTrials.gov (NCT01539057). The protocol was approved by the institutional review board (IRB) of the lead hospital (University Hospital of Bellvitge, approval number AC 033/18) as well as the IRBs of the other participating centres (University Hospital of Cruces and Clinic Hospital of Barcelona). Patients were enrolled if they gave their written informed consent. Results: Early tracheal extubation was performed in 149 patients (84.7%), and 27 patients (15.3%) required prolonged mechanical ventilation. Reoperations were required for 6.04% of the early extubated patients and 44% of patients who underwent prolonged ventilation (p = 0.001). A MELD score > 23 was the main risk factor for prolonged ventilation. Once modifiable risk factors were adjusted for MELD score, sex, and age, three factors were significantly associated with prolonged ventilation: tranexamic acid (p = 0.007) and red blood cell (p = 0.001) infusion and the occurrence of postreperfusion syndrome (p = 0.004). The median (IQR) ICU stay was 3 (2–4) days in the early extubation group vs. 5 (3–10) days in the prolonged ventilation group (p = 0.001). The median hospital stay was also significantly shorter after early extubation, at 14 (10–24) days, vs. 25 (14–55) days in the prolonged ventilation group (p = 0.001). Eight patients in the early-extubation group (5.52%) were readmitted to the ICU, nearly all for reoperations, with no between-group differences in ICU readmissions (prolonged ventilation group, 3.7%). Conclusion.: We conclude that bleeding and postreperfusion syndrome are the main modifiable factors associated with prolonged mechanical ventilation and length of ICU stay, suggesting that trials should explore vasopressor support strategies and other interventions prior to graft reperfusion that might prevent potential fibrinolysis.: Trial Registration.: European Clinical Trials Database (EudraCT 2018–002510-13,) and on ClinicalTrials.gov (NCT01539057)."