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Procedural-Related Bleeding in Hospitalized Patients With Liver Disease (PROC-BLeeD): An International, Prospective,
Nicolas M Intagliata1, Robert S Rahimi2, Fatima Higuera-de-la-Tijera3
1University of Virginia Health System, Charlottesville, Virginia.
Insights
Procedural bleeding in hospitalized cirrhosis patients is rare but serious. High-risk procedures, elevated BMI, and advanced liver disease predict bleeding events, not standard tests.
Area of Science:
- Hepatology
- Gastroenterology
- Internal Medicine
Background:
- Hospitalized patients with cirrhosis often require multiple procedures.
- The risk and management of procedural bleeding in this population are not well-defined.
Purpose of the Study:
- To determine the incidence of procedural-related bleeding in hospitalized cirrhosis patients.
- To identify independent risk factors for bleeding events.
Main Methods:
- An international, prospective, multicenter study involving 1187 patients undergoing 3006 nonsurgical procedures.
- Patients were monitored for 28 days post-admission or until a major event.
Main Results:
- Bleeding occurred in 6.9% of patient admissions and 3.0% of procedures; major bleeding in 2.3% and 0.9%, respectively.
- High-risk procedures, elevated Model for End-Stage Liver Disease (MELD) score, and higher Body Mass Index (BMI) independently predicted bleeding.
- Conventional hemostasis tests, prophylaxis, and antithrombotics were not predictive.
Conclusions:
- Procedural bleeding is infrequent in hospitalized cirrhosis patients.
- Patients with higher BMI and decompensated liver disease undergoing high-risk procedures face increased bleeding risk.
- Bleeding risk is not reliably predicted by standard tests or prophylaxis.
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.
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