Phase
Condition
Lung Injury
Gastrointestinal Diseases And Disorders
Primary Biliary Cholangitis
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subjects will be eligible to participate in the study if they meet allof the following criteria:
Admit to an ICU due to gastrointestinal bleeding AND an INR in first 12 hours >1.8; (INR ≥ 1.6 if received ≥ 2 units plasma)
Patient has chronic liver disease defined as 1 or more of the three followingdiagnostic criteria:
Previous diagnosis of chronic liver disease OR Imaging or biopsy diagnosis ofcirrhosis
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 liverdisease (palmar erythema, spider angiomata, asterixis, caput medusa,gynecomastia)
Exclusion
Exclusion Criteria:Subjects will be ineligible to participate in the study if they meet anyof the following criteria:
Patient under age 18 OR pregnant OR incarcerated
Patient meets criteria for acute respiratory distress syndrome (ARDS) (PaO2/FiO2<165)41
Patient admitted to ICU for re-bleed on same hospital admission OR has alreadyreceived >4 units of plasma.
Patient already underwent therapeutic endoscopy with noted hemostasis
History of inheritable or acquired clotting or bleeding disorder (hemophilia A or B oracquired clotting factor inhibitor)
Patient is being actively anticoagulated with vitamin K antagonists, direct thrombininhibitors, heparins or anti-Xa antagonists
Inability to obtain consent OR clinical team believes one of the transfusionstrategies will be harmful to the patient
Congestive heart failure (previous clinical diagnosis or Ejection Fraction (EF) <50%)
Patient is do-not-resuscitate (DNR) or unexpected to live > 72 hours
Study Design
Study Description
Connect with a study center
University of Colorado Hospital
Aurora, Colorado 80045
United StatesSite Not Available
Denver Health Hospitals
Denver, Colorado 80204
United StatesSite Not Available
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