Liver and Bile
Gastroenterology. 2023;165(3):717–32
Procedural-related bleeding in hospitalized patients with liver disease (PROC-BLeeD): An international, prospective, multicenter observational study
Background and aims: Hospitalized patients with cirrhosis frequently undergo multiple procedures. The risk of procedural-related bleeding remains unclear, and management is not standardized. The authors conducted an international, prospective, multicenter study of hospitalized patients with cirrhosis undergoing non-surgical procedures to establish the incidence of procedural-related bleeding and to identify bleeding risk factors.
Methods: Hospitalized patients were prospectively enrolled and monitored until surgery, transplantation, death, or 28 days from admission. The study enrolled 1187 patients undergoing 3006 non-surgical procedures from 20 centers.
Results: A total of 93 procedural-related bleeding events were identified. Bleeding was reported in 6.9% of patient admissions and in 3.0% of the procedures. Major bleeding was reported in 2.3% of patient admissions and in 0.9% of the procedures. Patients with bleeding were more likely to have non-alcoholic steatohepatitis (43.9% vs. 30%) and higher body mass index (BMI; 31.2 vs. 29.5). Patients with bleeding had a higher Model for End-stage Liver Disease (MELD) score at admission (24.5 vs. 18.5). A multivariable analysis controlling for center variation found that high-risk procedures (odds ratio [OR] = 4.64; 95% confidence interval [CI]: 2.44–8.84), MELD score (OR = 2.37; 95% CI: 1.46–3.86), and higher BMI (OR = 1.40; 95% CI: 1.10–1.80) independently predicted bleeding. Preprocedure international normalized ratio, platelet level, and antithrombotic use were not predictive of bleeding. Bleeding prophylaxis was used more routinely in patients with bleeding (19.4% vs. 7.4%). Patients with bleeding had a significantly higher 28-day risk of death (hazard ratio = 6.91; 95% CI: 4.22–11.31).
Conclusions: Procedural-related bleeding occurs rarely in hospitalized patients with cirrhosis. Patients with elevated body mass index and decompensated liver disease who undergo high-risk procedures may be at risk to bleed. Bleeding is not associated with conventional hemostasis tests, preprocedure prophylaxis, or recent antithrombotic therapy.