Predicting Lung Injury From Transfusion in Patients With Liver Disease

January 27, 2017 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver, Anshutz medical campus
      • Denver, Colorado, United States, 80207
        • Denver Health and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TRALI (consensus definition- with exception of absence of other acute lung injury risk factors)
Time Frame: 0-54 hours post enrollment
0-54 hours post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ratio of partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)
Time Frame: 0-54 hours post enrollment
0-54 hours post enrollment
Bleeding complications
Time Frame: 0-5 days post-enrollmnet
Baveno V criteria
0-5 days post-enrollmnet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 27, 2012

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0238

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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