Clinical trial NCT01756690: Predicting Lung Injury From Transfusion in Patients With Liver Disease
Official title: Endogenous Heparinoid Interference With Coagulation on Thromboelastogram as a Predictive Biomarker for Transfusion Related Acute Lung Injury (TRALI)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Transfusion-related Acute Lung Injury
Chronic Liver Disease
Gastrointestinal Bleeding
Keywords: respiratory distress syndrome, adult
blood component transfusion
gastrointestinal hemorrhage
blood coagulation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2012-12-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: TRALI (consensus definition- with exception of absence of other acute lung injury risk factors)
timeFrame: 0-54 hours post enrollment
Secondary outcomes:
measure: Change in ratio of partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)
timeFrame: 0-54 hours post enrollment
measure: Bleeding complications
timeFrame: 0-5 days post-enrollmnet
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver, Anshutz medical campus
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital
state: Colorado
Study officials:
References: