TY - JOUR
T1 - Procedural-Related Bleeding in Hospitalized Patients With Liver Disease (PROC-BLeeD)
T2 - An International, Prospective, Multicenter Observational Study
AU - Intagliata, Nicolas M.
AU - Rahimi, Robert S.
AU - Higuera-de-la-Tijera, Fatima
AU - Simonetto, Douglas A.
AU - Farias, Alberto Queiroz
AU - Mazo, Daniel F.
AU - Boike, Justin R.
AU - Stine, Jonathan G.
AU - Serper, Marina
AU - Pereira, Gustavo
AU - Mattos, Angelo Z.
AU - Marciano, Sebastian
AU - Davis, Jessica P.E.
AU - Benitez, Carlos
AU - Chadha, Ryan
AU - Méndez-Sánchez, Nahum
AU - deLemos, Andrew S.
AU - Mohanty, Arpan
AU - Dirchwolf, Melisa
AU - Fortune, Brett E.
AU - Northup, Patrick G.
AU - Patrie, James T.
AU - Caldwell, Stephen H.
N1 - Publisher Copyright:
© 2023 The Authors
PY - 2023/9
Y1 - 2023/9
N2 - Background & Aims: Hospitalized patients with cirrhosis frequently undergo multiple procedures. The risk of procedural-related bleeding remains unclear, and management is not standardized. We conducted an international, prospective, multicenter study of hospitalized patients with cirrhosis undergoing nonsurgical 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 nonsurgical 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 nonalcoholic 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 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), Model for End-Stage Liver Disease 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 BMI 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.
AB - Background & Aims: Hospitalized patients with cirrhosis frequently undergo multiple procedures. The risk of procedural-related bleeding remains unclear, and management is not standardized. We conducted an international, prospective, multicenter study of hospitalized patients with cirrhosis undergoing nonsurgical 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 nonsurgical 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 nonalcoholic 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 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), Model for End-Stage Liver Disease 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 BMI 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.
KW - Cirrhosis
KW - Hemostasis
KW - Obesity
KW - Prophylaxis
KW - Risk
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UR - http://www.scopus.com/inward/citedby.url?scp=85166184259&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2023.05.046
DO - 10.1053/j.gastro.2023.05.046
M3 - Article
C2 - 37271290
AN - SCOPUS:85166184259
SN - 0016-5085
VL - 165
SP - 717
EP - 732
JO - Gastroenterology
JF - Gastroenterology
IS - 3
ER -