Bleeding in Hospitalized Patients With Liver Disease Undergoing Invasive Procedures

Bleeding Clinical Trial

— PROC-BLeeD  

Official title:

Bleeding in Hospitalized Patients With Liver Disease Undergoing Invasive Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076605
• Other study ID #: 21671
• Status: Completed
• Start date: November 15, 2019
• Est. completion date: July 29, 2022

Study information

• Verified date: November 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Hospitalized patients with cirrhosis who undergo 1 or more non-surgical procedure will be enrolled. The investigators will collect multiple clinical characteristics from the medical record and follow the patients prospectively over the hospitalization and/or until 28 days to determine if clinical events have occurred including bleeding, thrombosis, re-hospitalization and death. Characteristics of the hospitalization will be recorded including presence of acute decompensation and acute on chronic liver failure (ACLF). Procedure type will be recorded including coagulation laboratory data before and after each procedure. All bleeding events will be recorded and characteristics surrounding each bleed will be recorded. Bleeding will be defined according to International Thrombosis and Haemostasis (ISTH) definitions of major bleed and clinically relevant non-major bleed. REDCap (https://www.project-redcap.org) will be used to collect and centralize data maintained at the University of Virginia. Characteristics of each hospitalization will be recorded accordingly and patients will be followed for 28 days for outcome and mortality information. Each participating center will obtain local Institutional Review Board (IRB) approval to participate and enter data directly into REDCap. After center IRB approval is obtained, centers will consecutively enrolling patients on a rolling basis. Data will be collected from enrollment until death, transplant, discharge and/or 28 days on each individual enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1182
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bleeding
• Blood Coagulation Disorders
• Cirrhosis, Liver
• Coagulation Disorder, Blood
• Hemorrhage
• Hemostatic Disorders
• Liver Cirrhosis
• Liver Diseases
• Procedural Complication

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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