Prospective Validation of a Plasma Transfusion Dosing Algorithm in Patients With Chronic Liver Disease
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      Clinicians currently transfuse plasma to International Normalized Ratio (INR) targets without
      an understanding of the dose response characteristics of plasma in bleeding patients with
      liver disease. Epidemiologic studies show that INR is infrequently corrected to target INR
      values after clinician chosen plasma transfusion doses in patients with liver disease. Plasma
      transfusion is frequently given to patients prior to procedures and during active bleeding in
      this patient population though there are no dosing guidelines to aid clinicians in reaching
      INR targets in patients with liver disease. Previous studies suggest that patients with liver
      disease may need more plasma then patients without liver disease to correct any given
      pre-transfusion INR (INR value measured before plasma transfusion) to the same
      post-transfusion INR target (INR value measured after plasma transfusion).

      Current physician dosing of plasma is variable and rarely successful at reaching stated INR
      targets. The INR thresholds, commonly used triggers for plasma transfusion by
      Gastro-Intestinal (GI), Hepatology and critical care physicians at our institution range from
      1.5-3.0 in bleeding or pre-procedural patients with liver disease representing tremendous
      variability. When we evaluated plasma transfusion dosing practices in bleeding patients with
      liver disease over 8 years, we demonstrated that these same physicians rarely met stated
      theoretical targets.

      Over or under dosing plasma in these patients may lead to serious clinical complications.The
      target INR goal was to be within ±0.1 after the first round of FFP transfusion, and was
      selected because underdosing can result in prolonged bleeding, delayed procedure times, and
      more rounds of FFP transfusion. Furthermore, overdosing can result in excess cost, increased
      portal pressures, bleeding, transfusion associated circulatory overload (TACO), and
      transfusion related acute lung injury (TRALI).
    

Intervention name(s): Fresh Frozen Plasma; Pre-Transfusion International Normalized Ratio (INR); Post-Transfusion International Normalized Ratio (INR)
Intervention type(s): Biological; Diagnostic Test; Diagnostic Test
Intervention description(s): 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.
Other intervention name(s): FFP; Pre-Transfusion INR; Post-Transfusion INR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment