Prospective Validation of a Plasma Transfusion Dosing Algorithm in Patients With Chronic Liver Disease
Condition: Liver Disease
MeSH terms: Liver Diseases
Intervention: Fresh Frozen Plasma; Pre-Transfusion International Normalized Ratio (INR); Post-Transfusion International Normalized Ratio (INR)
Intervention description: An INR dose-response curve with associated transfusion algorithm was generated for plasma in bleeding patients with chronic liver disease. In the intervention arm we will determine the plasma transfusion dose using the algorithm dosing table based on the pre-transfusion INR and the clinician chosen INR target. In the usual care group the dosing will be determined by the clinician.; INR result prior to Fresh Frozen Plasma (FFP) transfusion determined by clinical lab testing performed within 6 hours to 1 day before transfusion start time.; INR result after Fresh Frozen Plasma (FFP) transfusion completed, determined by clinical lab testing performed within 1 hour after transfusion completed.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study plans to learn more about transfusion of a human blood component called plasma in
      patients who have liver problems. Patients are asked to be in this study because they have
      liver disease and therefore may require the transfusion of plasma.

      The dose of plasma required to reach certain blood clotting laboratory targets is usually
      determined by clinicians. Due to the complexity of the patient's blood clotting disorder,
      determining the appropriate dose of plasma is very difficult. The investigators have
      developed a dosing table based on information from other patients with liver disease and the
      investigators are testing it to see if it is a more accurate dosing tool then clinician
      chosen dosing of plasma in patients with liver disease who need one or more plasma
      transfusions
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects will be eligible to participate in the study if they meet all of the following
        criteria:

          1. Admission to the University of Colorado Hospital or Denver Health hospital and the
             clinical care team plans to transfuse the patient plasma to target a specific INR
             value. (reason for transfusion is not considered).

          2. Patient has chronic liver disease defined as 1 or more of the following: Previous
             diagnosis of chronic liver disease OR -Imaging or biopsy diagnosis of cirrhosis; or

          3. Signs of portal hypertension (ascites, varices, hypersplenism), or

          4. Laboratory evidence of synthetic dysfunction (INR>1.5, bilirubin> 2.0 mg/dL,
             albumin<2.5 mg/dL) 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

          2. Patient actively taking vitamin K antagonists

          3. Inability to obtain consent

          4. Clinical team does not desire to target a specific INR value

          5. Pregnant patients and prisoners

          6. Patients with Acute Liver Failure