Predicting Lung Injury From Transfusion in Patients With Liver Disease

Chronic Liver Disease Clinical Trial

Official title:

Endogenous Heparinoid Interference With Coagulation on Thromboelastogram as a Predictive Biomarker for Transfusion Related Acute Lung Injury (TRALI)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01756690
• Other study ID #: 09-0238
• Status: Terminated
• Phase: N/A
• First received: December 20, 2012
• Last updated: January 27, 2017
• Start date: October 2011
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A certain molecule floating in the blood may represent a risk of lung injury after a transfusion. We are determining whether detection of this molecule on a simple blood clotting test will predict the development of lung injury due to transfusion in bleeding patients with chronic liver disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion criteria: Subjects will be eligible to participate in the study if they meet all of the following criteria:

1. Admit to an ICU due to gastrointestinal bleeding AND an INR > 1.5

2. Patient has chronic liver disease defined as 1 or more of the three following diagnostic criteria:

1. Previous diagnosis of chronic liver disease OR Imaging or biopsy diagnosis of cirrhosis

2. Signs of portal hypertension (ascites, varices, hypersplenism)

3. Laboratory evidence of synthetic dysfunction (INR>1.5, Bilirubin> 2.0, Albumin< 2.5) AND =2 physical exam findings on admission associated with chronic liver disease (palmar erythema, spider angiomata, asterixis, caput medusa, gynecomastia)

Exclusion criteria: Subjects will be ineligible to participate in the study if they meet any of the following criteria

1. Patient under age 18 OR pregnant OR incarcerated

2. Patient meets criteria for acute respiratory distress syndrome (ARDS) (PaO2/FiO2<165)

3. Patient admitted to ICU for re-bleed on same hospital admission OR has already received >4 units of plasma.

4. History of inheritable or acquired clotting or bleeding disorder

5. Patient actively anticoagulated or has recently received (within 72h) vitamin K antagonists, direct thrombin inhibitors, heparins or Xa antagonists

Related Conditions & MeSH terms

• Acute Lung Injury
• Chronic Liver Disease
• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Liver Diseases
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Transfusion-related Acute Lung Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	University of Colorado Denver, Anshutz medical campus	Aurora	Colorado
United States	Denver Health and Hospital	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TRALI (consensus definition- with exception of absence of other acute lung injury risk factors)		0-54 hours post enrollment
Secondary	Change in ratio of partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)		0-54 hours post enrollment
Secondary	Bleeding complications	Baveno V criteria	0-5 days post-enrollmnet