Bleeding in Hospitalized Patients With Liver Disease Undergoing Invasive Procedures

NCT04076605 | Completed

• 1 other identifier: 21671
• Study Type: observational
• Target: 1,182
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with cirrhosis are frequently hospitalized and often undergo procedures. Knowledge surrounding bleeding risk is sparse and practice patterns vary across centers in regards to bleeding prophylaxis. The goal of this study to is to obtain more knowledge regarding risk factors for procedural related bleeding in patients with cirrhosis and to develop a predictive model to risk stratify patients before undergoing procedures. Through collaboration from centers across the world this study should provide information on prevalence of bleeding and variation in practice patterns for prophylaxis.

Conditions

Bleeding; Procedural Complication; Cirrhosis, Liver; Coagulation Disorder, Blood

Keywords

Decompensated; Liver; Coagulopathy; ACLF

Outcome Measures

Primary Outcomes (1)

• Prevalence of procedural-related bleeding events in patients with cirrhosis

  During each hospitalization every procedure will be recorded and details surrounding each bleeding event related to a procedure will be recorded.

  Each patient enrolled will be followed for 28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with cirrhosis admitted to the hospital are evaluated and then consented to participate in the study (see Inclusion/Exclusion). Patients with cirrhosis admitted to the general ward or intensive care unit may be enrolled. The investigators will collect multiple clinical characteristics from the medical record and follow the patients over the hospitalization and/or until 28 days to determine if clinical events have occurred including bleeding, thrombosis, re-hospitalization and death.

You may qualify if:

• Adult patients with cirrhosis admitted to a hospital ward or ICU for greater than 24 hours.
• Patient must undergo 1 or more invasive non-surgical procedures at admission or during the hospitalization.

You may not qualify if:

• Age \< 18 years old
• Prisoner
• Pregnant
• Unable to provide consent
• Previously enrolled in this study

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Hemorrhage; Liver Cirrhosis; Blood Coagulation Disorders; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders

Study Officials

• Nicolas M Intagliata, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Gastroenterology

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: November 15, 2019
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

US (1)