Presumed to have an inherent high risk for procedure-related bleeding, cirrhosis patients have long experienced compromised care. An ambitious UVA Health-initiated study aims to provide the definitive clinical data needed to improve care for this complex patient population.
“Our study will be, by far, the largest study on nonsurgical procedure bleeding in cirrhosis patients. It will help corroborate expert treatment guideline consensus and demonstrate which patients would be potentially at higher risk for hemostasis-related bleeding and thrombosis,” says UVA Health hepatologist Nicolas Intagliata, MD, MS, leading the study.
He adds, “An important component of this study is to quite clearly show that the factors we classically associate with bleeding do not predict bleeding in cirrhosis patients.”
3,000 Procedures Analyzed at 20 Institutions
In their prospective observational study, the UVA Health investigators followed 1,187 patients with cirrhosis at 20 participating centers across North and South America. Launched right before the COVID pandemic, the study recently closed to enrollment. The UVA team is finishing up its analysis and preparing the manuscript to submit for publication.
The abstract was accepted for presentation at the Digestive Disease Week meeting in May 2023.
“The impetus of this study was to build on smaller retrospective work so we could collect as much data as possible on patients with cirrhosis who come into the hospital,” Intagliata says.
He adds, “Our study included fairly sick patients undergoing a total of 3,000 nonsurgical procedures such as endoscopy or biopsy. We then followed them to see who developed bleeding. Recognizing that bleeding is a rare event, we needed a lot of patients to increase external validity.”
Building on Pioneering UVA Health Hepatology Research
The observational study builds on pioneering research at UVA Health that helped overturn a long-held misconception that even today negatively impacts liver disease patients.
Intagliata’s colleague, Stephen Caldwell, MD, is well known in the field for his research on coagulopathy disorders within liver disease. Caldwell’s work helped undo the assumption that patients with liver disease, and primarily patients with cirrhosis, have an inherent risk of bleeding when undergoing procedures.
Research has shown over the last 20 years, Intagliata says, that “While patients with cirrhosis do have a complex coagulation system, they have factors to help them rebalance and compensate to prevent bleeding or clotting.”
So why, then, the persistence of this erroneous assumption?
Intagliata points out the reason, saying, “The problem is the tests we have to evaluate that risk — primarily platelet levels and INR (international normalized ratio) — are quite misleading in cirrhosis patients.”
Taken at face value, typical lab results can seem to suggest a bleeding risk that doesn’t exist.
While the gastroenterology and hepatology world may know about the misleading tendencies of these labs, other specialists don’t.
This has led to somewhat compromised care of patients with cirrhosis. Intagliata notes, “They may not get necessary procedures done, or if they do, they'll unnecessarily get platelet or plasma transfusions.”
Which is why an understanding of cirrhosis and bleeding needs to disseminate to interventional radiologists, cardiologists, anesthesiologists, and other proceduralists working in intensive care units.
Why Correct ID Is So Crucial
Moving this research forward has become even more important given the pandemic-related shortages of blood products. “That’s becoming a major issue. Reducing unnecessary transfusions is important, not only for the broader public, but also for the liver disease patient as these transfusions can have significant side effects,” Intagliata says.
The takeaways from this research translate to a clear message. Intagliata hopes anyone performing procedures will use this data to understand and be reassured that while some cirrhosis patients do develop bleeding, the majority don't.
“Our goal is to use our study findings to develop a risk assessment model to clearly define the group that is at higher risk for bleeding.”
Dive Deeper: Managing Cirrhosis Patients
Intagliata and Caldwell coauthored a 2022 Journal of Hepatology review on the clinical management of hemostasis in cirrhosis patients.
Intagliata is a coauthor on Vascular Liver Disorders guidelines from the American Association for the Study of Liver Diseases (AASLD).
Intagliata is the first author on the American Gastroenterological Association Technical Review on Coagulation in Cirrhosis.