Predicting Lung Injury From Transfusion in Patients With Liver Disease

This study is currently recruiting participants.
Verified July 2013 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01756690
First received: December 20, 2012
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endogenous Heparinoid Interference With Coagulation on Thromboelastogram as a Predictive Biomarker for Transfusion Related Acute Lung Injury (TRALI)

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • TRALI (consensus definition- with exception of absence of other acute lung injury risk factors) [ Time Frame: 0-54 hours post enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in ratio of partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) [ Time Frame: 0-54 hours post enrollment ] [ Designated as safety issue: No ]
  • Bleeding complications [ Time Frame: 0-5 days post-enrollmnet ] [ Designated as safety issue: No ]
    Baveno V criteria


Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756690

Locations
United States, Colorado
University of Colorado Denver, Anshutz medical campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Alex b Benson, MD    303-724-6063    alexander.benson@ucdenver.edu   
Principal Investigator: Alexander B Benson, MD         
Denver Health and Hospital Recruiting
Denver, Colorado, United States, 80207
Contact: Alexander B Benson, MD    303-724-6063    alexander.benson@ucdenver.edu   
Principal Investigator: Alexander B Benson, MD         
Sponsors and Collaborators
University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01756690     History of Changes
Other Study ID Numbers: 09-0238
Study First Received: December 20, 2012
Last Updated: July 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
respiratory distress syndrome, adult
blood component transfusion
gastrointestinal hemorrhage
blood coagulation

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Liver Diseases
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Wounds and Injuries
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries

ClinicalTrials.gov processed this record on April 17, 2014