Predicting Lung Injury From Transfusion in Patients With Liver Disease

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01756690

Enrollment

Registered

2012-12-27

Start date

2011-10-31

Completion date

2016-12-31

Last updated

2017-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

respiratory distress syndrome, adult, blood component transfusion, gastrointestinal hemorrhage, blood coagulation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results