Predicting Lung Injury From Transfusion in Patients With Liver Disease



Status:Recruiting
Conditions:Hospital, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:18 - 85
Updated:5/3/2014
Start Date:October 2011
End Date:December 2016

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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.


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
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