Predicting Lung Injury From Transfusion in Patients With Liver Disease

NCT01756690 | Terminated DMC

• 1 other identifier: 09-0238
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Transfusion-related Acute Lung Injury; Chronic Liver Disease; Gastrointestinal Bleeding

Keywords

respiratory distress syndrome, adult; blood component transfusion; gastrointestinal hemorrhage; blood coagulation

Outcome Measures

Primary Outcomes (1)

• TRALI (consensus definition- with exception of absence of other acute lung injury risk factors)

  0-54 hours post enrollment

Secondary Outcomes (2)

• Change in ratio of partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)

  0-54 hours post enrollment

• Bleeding complications

  0-5 days post-enrollmnet

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with chronic Liver disease admitted to an intensive care unit with a gastrointestinal bleed and INR\> 1.5 who may receive plasma transfusion therapy.

You may qualify if:

• Admit to an ICU due to gastrointestinal bleeding AND an INR \> 1.5
• Patient has chronic liver disease defined as 1 or more of the three following diagnostic criteria:
• Previous diagnosis of chronic liver disease OR Imaging or biopsy diagnosis of cirrhosis
• Signs of portal hypertension (ascites, varices, hypersplenism)
• 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)

You may not qualify if:

• Patient under age 18 OR pregnant OR incarcerated
• Patient meets criteria for acute respiratory distress syndrome (ARDS) (PaO2/FiO2\<165)
• Patient admitted to ICU for re-bleed on same hospital admission OR has already received \>4 units of plasma.
• History of inheritable or acquired clotting or bleeding disorder
• Patient actively anticoagulated or has recently received (within 72h) vitamin K antagonists, direct thrombin inhibitors, heparins or Xa antagonists

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Denver, Anshutz medical campus

Aurora, Colorado, 80045, United States

Location

Denver Health and Hospital

Denver, Colorado, 80207, United States

Location

MeSH Terms

Conditions

Transfusion-Related Acute Lung Injury; Gastrointestinal Hemorrhage; Respiratory Distress Syndrome; Thrombosis

Condition Hierarchy (Ancestors)

Acute Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Transfusion Reaction; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 27, 2012
• Study Start: October 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2016
• Last Updated: January 30, 2017

Record last verified: 2017-01

Locations

US (2)