TerminatedNot Applicable

Predicting Lung Injury From Transfusion in Patients With Liver Disease

Stopped: Recruitment

United States16 participantsStarted 2011-10

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Admit to an ICU due to gastrointestinal bleeding AND an INR \> 1.5
✓. Patient has chronic liver disease defined as 1 or more of the three following diagnostic criteria:
✓. Previous diagnosis of chronic liver disease OR Imaging or biopsy diagnosis of cirrhosis
✓. Signs of portal hypertension (ascites, varices, hypersplenism)
✓. 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

✕. Patient under age 18 OR pregnant OR incarcerated
✕. Patient meets criteria for acute respiratory distress syndrome (ARDS) (PaO2/FiO2\<165)
✕. Patient admitted to ICU for re-bleed on same hospital admission OR has already received \>4 units of plasma.
✕. History of inheritable or acquired clotting or bleeding disorder
✕. Patient actively anticoagulated or has recently received (within 72h) vitamin K antagonists, direct thrombin inhibitors, heparins or Xa antagonists

What they're measuring

TRALI (consensus definition- with exception of absence of other acute lung injury risk factors)

Timeframe: 0-54 hours post enrollment

Trial details

NCT IDNCT01756690

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-10

View on ClinicalTrials.gov More Transfusion-related Acute Lung Injury trials