Predicting Lung Injury From Transfusion in Patients With Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01756690
Recruitment Status : Terminated (Recruitment)
First Posted : December 27, 2012
Last Update Posted : January 30, 2017
Information provided by (Responsible Party):
University of Colorado, Denver

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.

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

Study Type : Observational
Actual Enrollment : 16 participants
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)
Study Start Date : October 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2016

Primary Outcome Measures :
  1. TRALI (consensus definition- with exception of absence of other acute lung injury risk factors) [ Time Frame: 0-54 hours post enrollment ]

Secondary Outcome Measures :
  1. Change in ratio of partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) [ Time Frame: 0-54 hours post enrollment ]
  2. Bleeding complications [ Time Frame: 0-5 days post-enrollmnet ]
    Baveno V criteria

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756690

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

Responsible Party: University of Colorado, Denver Identifier: NCT01756690     History of Changes
Other Study ID Numbers: 09-0238
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017

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

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