Clinical trial NCT04076605: Bleeding in Hospitalized Patients With Liver Disease Undergoing Invasive Procedures
Official title: Bleeding in Hospitalized Patients With Liver Disease Undergoing Invasive Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding
Procedural Complication
Cirrhosis, Liver
Coagulation Disorder, Blood
Keywords: Decompensated
Liver
Coagulopathy
ACLF
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 1182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of procedural-related bleeding events in patients with cirrhosis
timeFrame: Each patient enrolled will be followed for 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Nicolas M Intagliata, MD
role: PRINCIPAL_INVESTIGATOR
References: